Career Opportunities

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: People Leader All Job Posting Locations: Irvine, California, United States of America Job Description: We are searching for the best talent for a Manager, Regulatory Affairs (International Regulations) to be located in Irvine, CA. This role will work a Flex/Hybrid schedule with 3 days per week in office. Purpose: The Manager, Regulatory Affairs, International Registrations develops and implements regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards. You will be responsible for: • Manages a team of individual contributors and/or supervisors, ensuring the effective identification and preparation of detailed international registration documentation that supports all stages of a medical device's lifecycle, from initial product registration through end-of-life, while meeting the documentation needs for international JNJ affiliates. • Directs resources to develop and implement methods for planning, directing, coordinating, and controlling the submission of international Regulatory documents to Regulatory agencies, including responses to global Health Authority inquiries. • Develops and sustains strategic relationships with RA affiliates, advising on the development and execution of local registration strategy. • Benchmarks Regulatory Affairs strategies, assessments, and policies to guide cross-functional teams on international RA issues in developing registration plans to ensure timely commercialization of new and modified products in international markets. • Ensures compliance by communicating the interpretation of new and changing government regulations to uphold regulatory/government standards. • Oversees the maintenance of Regulatory Affairs databases and communication tools, including the SharePoint site, Regulatory databases, request tracking systems, and electronic libraries. • Assists with the development of product policies by reviewing, and revising company SOPs as required. • Supervises interaction with internal and external stakeholders to manage the procurement of necessary documentation for international regulatory activities. • Develops tactical plans for global planning to ensure visibility, alignment, and optimal resource allocation. • Provides support for internal and external regulatory agency audits, when necessary. • Manages operational aspects of their team (e.g., workflow, performance, and compliance), and ensures achievement of team goals within established timelines and budgets. • Responsible for communicating business related issues or opportunities to next management level. • Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. • For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable. • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. • Performs other duties assigned as needed. Qualifications / Requirements: • Minimum of a Bachelor’s Degree required, Advanced Degree strongly preferred. • At least 8+ years of relevant experience in the medical device industry with at least 6+ years in Regulatory Affairs of Medical Devices. • Minimum 2 years of supervisory experience. • Regulatory experience in the cardiovascular/cardiology field and/or with devices containing software strongly preferred. • Experience in international regulatory requirements (APAC/LATAM/EMEAC) for medical devices highly desired. • Proven ability to manage a diverse globally dispersed team is preferred. • Proven expertise in international regulatory requirements and ability to translate regulations into clear deliverables to support registrations and ensure lifecycle maintenance of all products. • Strong understanding of Medical Device regulations / standards and Quality principles. • Extensive hands-on experience in activities such as product approval applications, regulatory submission management and negotiation with regulatory bodies worldwide. Ability to manage multiple priorities effectively. • Strong interpersonal and organizational and problem-solving skills. • A strong results-orientation and sense of urgency. • Ability to partner and influence key stakeholders within MedTech RA and cross functional business partners. • Excellent written and verbal communications skills in English (required). Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource. #LI-Hybrid The anticipated base pay range for this position is : The base pay range for this position is $115,000 to $197,800. Additional Description for Pay Transparency: The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource. #LI-Hybrid

Job Description The Sr. Manager, Regulatory Affairs for Getinge's Endovascular product area within our global Acute Care Therapy business area will be responsible for partnering with R&D and Marketing as well as other cross-functional team members to develop and implement global regulatory strategies to drive pipeline development and global launch excellence. This position will manage and direct the preparation, submission, tracking of official documents and files such as Pre-Market Approval applications (including Supplements, Amendments, and Annual Reports), IDEs, 510(k)s, Technical Documentation and other applicable country regulatory submissions and requirements. This position will be primarily responsible for Getinge's Class III balloon-expandable covered stent product portfolio and will have responsibility to manage and develop the regulatory department staff supporting these products (two direct reports). Responsibilities • Develop and oversee the implementation of strategies for new product development and life cycle design and manufacturing improvements to obtain and maintain global product licenses. The Endovascular regulatory team is directly responsible for U.S. FDA submissions and EU Notified Body submissions. • Pro-actively ensure strategies are adapted to changing regulatory requirements, provide robust input to project teams to drive predictability of regulatory timelines, and raise awareness of potential issues and risks early and to appropriate stakeholders, including providing regulatory solutions for the Endovascular product area. • Ensures the quality of submissions generated. Provides expertise and consultation on proper preparation of submission documentation and files to relevant departments. Liaises with internal organizations to provide/solicit guidance and support for complex submissions. • Main point of contact for regulatory authorities, managing all communication, including pre-submissions and meetings with regulatory bodies. • Leverage a deep scientific and technical understanding of products under the scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products. • Assures that a positive working relationship is developed and maintained between staff and internal/external customers. • Leads or assists with internal and external health authority audits for Regulatory department. • Oversees and/or owns CAPAs pertaining to Regulatory department. • Develops and maintains high level relationships with key contacts in regulatory agencies and trains junior team members on effective Health Authority meeting techniques and preparation. • Encourage and lead others to find ways to continuously improve, learn about new scientific, technological, and Regulatory developments, develop new capabilities, and learn from past challenge and experience in order to proactively adapt to change and drive innovative thinking. • Monitors compliance with company policies and regulatory procedures consistent with EU and FDA. • This position interacts directly with both external and internal auditors as the Subject Matter expert to ensure that the company's global change control process maintains compliance to internal and external regulations. • Assists in special projects as needed. Requirements • A bachelor's degree in engineering, Science or related field is required. A Master of Science in Engineering, Science or related field or MBA is preferred. • A minimum of 10 years medical device regulatory experience is required. • RAC designation is preferred. • People Leadership experience including management direct reports and developing team members is preferred. • Experience leading interactions and negotiating with global Health Authorities (i.e. U.S. FDA, EU Notified Bodies) is required, including leading and/or assisting with Health Authority audits. • Expertise in developing and executing successful regulatory strategies for U.S. Class III PMA devices and EU Class III devices is required. • Experience with navigating regulatory compliance challenges (i.e. consent decree, field actions) is required. • Understands the requirements of FDA 21CFR Part 820, EU MDR, MDSAP, CMDR and ISO 13485 and strong experience with standards management. • Must have FDA and Notified Body interaction experience • Must have in depth knowledge of regulatory requirements • Must have experience with global labeling requirements • Must have solid knowledge and experience in matters relating to organizational skills and personnel management. • Must demonstrate effective written and verbal communication skills, including technical writing skills. • Must have experience with and have strong knowledge of regulatory submissions including Pre-Market Approval applications (PMA) and 510(k) Notifications. Additional experience with IDE and De Novo submissions is a plus. • Must have demonstrated ability to mentor and develop a high performing staff. • Team player who can communicate and collaborate proactively with all staff members to achieve corporate and project goals. • Must be detail oriented and possess excellent organizational skills with a demonstrated ability to manage multiple projects with strict deadlines. • Computer skills must include comprehensive knowledge of all current and common computer tools (e.g. MS-Excel, MS-PowerPoint, MS-Word) as well as some specialized applications.

Who We Are At Freshpet, our goal is to change the way people nourish their pets forever. We strive to strengthen the bond between people and our pets so that we both live longer, healthier, and happier lives while being kind to the planet. We believe that if we can create fresh, real foods that pets love and help them live healthier lives, that their pet parents will also enjoy the many benefits of a rich life shared with a pet. IT’S AMAZING WHAT CAN HAPPEN WHEN YOU START COMPLETELY FRESH! What You Will Do The Manager, Regulatory Affairs, will report to the VP of Government and Regulatory Affairs. The role offers an opportunity to lead critical regulatory processes, drive cross-functional collaboration, and shape the future of Freshpet's products in compliance with U.S. and global regulations. As the Manager, Regulatory Affairs, you will help ensure Freshpet’s products meet all regulatory requirements for research and development, manufacturing, distribution, marketing, and sales across the U.S. and Canada. You will be a key member of the regulatory claims team, review ingredient/raw material processes, monitor changes in the regulatory landscape, and build strong internal and external relationships. This role will help drive process improvements to ensure compliance and operational excellence. How You Will Make an Impact Regulatory Claims: • Help manage the marketing review process, ensuring compliance with regulations for on-pack and campaign claims. • Identify and address claims issues, providing strategic alternatives that align with business needs. • Influence technical, business, and policy decisions through regulatory expertise. Ingredient/Raw Material Regulatory Oversight: • Lead the regulatory ingredient process in the qualification, review, and documentation processes for new ingredients and suppliers. • Monitor and evaluate regulatory changes that impact Freshpet’s current and future operations. Building Relationships and Advocacy: • Foster a collaborative environment across functions such as Marketing, Legal, Supply Chain, and R&D. • Assist manager in representing Freshpet with key trade associations in US and Canada. • Present critical regulatory information to the Manager to assist in decision-making. People Management and Operational Excellence: • Drive process improvement initiatives to maximize efficiency and minimize risks. • Facilitate knowledge sharing and maintain a culture of continuous learning and development within the regulatory team. What You Will Bring Qualifications: Required: • Bachelor’s degree in animal sciences or a related field. • Minimum of 3-5 years of experience in Regulatory Affairs, pet food experience preferred. • Proven experience in preparing regulatory submissions, reviewing product claims, and interpreting product regulations. Preferred: • Supervisory or management experience. • Expertise in interpreting AAFCO guidelines and U.S. regulations (e.g., FDA, CVM, USDA). • Strong verbal and written communication skills, with the ability to convey complex regulatory information to diverse audiences. • Exceptional collaboration, time management, and organizational skills. • Customer service oriented with a proactive approach to problem-solving. What We Offer The range for this position is: $130,000 - $155,0000 At Freshpet, we offer a competitive salary and an excellent benefits package, including medical, dental and vision insurance, basic and optional life insurance, short- and long-term disability protection, flexible spending accounts, and a 401(k) plan with company match, paid parental leave, pet insurance, tuition assistance, a generous PTO plan and so much more! Our Commitment to a Diverse Workforce Freshpet is an Equal Opportunity Employer. All employment decisions are made without regards to race, color, national origin, religion, creed, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, marital or domestic/civil partnership status, genetic information, citizenship status (although applicants and employees must be legally authorized to work in the United States), uniformed service member or veteran status, or any other characteristic protected by applicable federal, state, or local law (“protected characteristics”). Disclaimers The salary range provided above is the range of the wages that we will pay for the listed position. A final determination on the wages within this range is based on a number of non-discriminatory factors, including but not limited to the required work location, previous work experience, skill set, and wage rates for comparable positions. Freshpet is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Freshpet via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Freshpet. No fee will be paid in the event the candidate is hired by Freshpet as a result of the referral or through other means. We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to sponsor visas. #LI-RK1

Working Location: MASSACHUSETTS, WESTBOROUGH; NATIONWIDE Workplace Flexibility: Field For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​ ​ Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. ​ Our five Core Values empower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy. Learn more about Life at Olympus. Job Description Assist the Manager, Regulatory Affairs in obtaining approval to market Olympus medical devices in the markets served by Olympus Job Duties • Facilitate development of regulatory strategy for novel technologies or market segments, that lead to product teams responsible for developing new products. Where tasked by Regulatory Management, assist with Business Development opportunities, including due diligence assessments of regulatory posture, research, and capabilities. • Responsible for review and approval of product labeling (including IFU) and other ancillary labeling-related matters. Work closely with Upstream Marketing and the Regulatory Labeling Team in developing labeling materials. Responsible for development, coordination, preparation and maintenance of US medical device submissions such as Pre-Submissions,510ks, PMAs, IDEs and applicable supplement sand annual reports and liaise with FDA reviewers as needed • Where designated, responsible for development, coordination, preparation and maintenance of medical device submissions for Canadian Class 2, 3 or 4Device License submissions. Lead development of responses to regulatory authorities’ requests for additional information. • Where designated, interface with the EU Submissions Team to support preparation of dossiers and technical files for registration of Olympus products in the EU. Interface with International Regulatory Affairs Team to support preparation of dossiers for registration for other international markets such as Japan, the Far East, Australia and Latin America. • Responsible for keeping abreast of changes and proposed changes to the worldwide regulatory requirements related to our products and processes. May be tasked to formally advise regulatory and business management of changes and as appropriate communicate regulatory initiatives or changes to other OSTA staff. Responsible for maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information and to provide reports to management concerning current, pending, and future approvals to management. Job Qualifications Required: • BS/BA required, preferably in engineering or life sciences. RAC accreditation or Post-graduate degree preferred. • Regulatory affairs experience in the Medical Device industry is mandatory (minimum 10 years with BS/BA, or 7 years with MS preferred). • Regulatory affairs experience in writing US submissions and EU submissions is mandatory and experience in collaboration and working with the Regulatory Authorities directly is mandatory. Why join Olympus? We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture. Equitable Offerings you can count on: • Competitive salaries, annual bonus and 401(k)* with company match • Comprehensive medical, dental, vision coverage effective on start date • 24/7 Employee Assistance Program • Free live and on-demand Wellbeing Programs • Generous Paid Vacation and Sick Time • Paid Parental Leave and Adoption Assistance* • 12 Paid Holidays • On-Site Child Daycare, Café, Fitness Center** Connected Culture you can embrace: • Work-life integrated culture that supports an employee centric mindset • Offers onsite, hybrid and field work environments • Paid volunteering and charitable donation/match programs • Employee Resource Groups • Dedicated Training Resources and Learning & Development Programs • Paid Educational Assistance • US Only • *Center Valley, PA and Westborough, MA Are you ready to be a part of our team? Learn more about our benefit and incentives. The anticipated base pay range for this full-time position working at this location is $104,061.00 - $145,685.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications. At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com. You Belong at Olympus We value a workforce that reflects a wide range of perspectives, backgrounds, and experiences. We foster an environment where all employees feel valued, respected, and supported. And we provide employees with equal access to opportunities for growth and development. Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787). Let’s realize your potential, together. It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)

Job Level: Technical Leadership-T2 Job Description: Are you passionate about shaping the future of pet nutrition and eager to make a meaningful impact? Join the Royal Canin Regulatory Affairs department as a pivotal member of the Global Market Access Strategy team. In this dynamic role, you will play a crucial part in ensuring our innovative portfolio can access markets seamlessly and in compliance with all relevant regulations. Your expertise will be instrumental in maximizing the potential of our innovations, particularly within the Pet Supplements business. You will be at the forefront of shaping the future regulatory environment, leveraging our Regulatory Sciences and Advocacy capabilities. By proactively anticipating how evolving regulations and standards will impact compliance criteria for products and claims, as well as technical & sanitary requirements for raw materials & products, you will navigate the complexities of the regulatory environment. Your insights will directly inform product design and manufacturing strategies, empowering us to promote our distinctiveness in the market with speed and agility. As we adapt to disruptive sciences and technologies, your role will be vital in creating new regulatory frameworks that support our innovations. What are we looking for? Minimum Requirements • Bachelor’s Degree (preferably in Biological Sciences, Nutrition, Biochemistry, Food Science, Animal Science, or related technical field) • 7+ years of professional experience, including 3 to 5 years specifically in Regulatory Affairs (and/or R&D roles closely aligned with regulatory and market access topics) within the food, feed, or pet food sectors; Animal/ Feed Supplement industry experience is a plus. • Regulatory expertise: in-depth knowledge of food product law, particularly in the US regulatory framework; familiarity with regulations in China and the EU is a plus. • A confident, action-oriented individual with strong communication skills, capable of effectively presenting information and collaborating across diverse organizational and cultural boundaries. • Proven ability to influence stakeholders and manage projects and portfolios, demonstrating strong problem-solving capabilities. • Fluent in English, any additional language is a plus (French, Chinese, German, or Spanish) • Up to 15% travel required (domestic/international) Preferred Qualifications • Advanced Degree in Biological Sciences, Nutrition, Biochemistry, Food Science, Animal Science, or related technical field What will be your key responsibilities? • Regulatory Strategy Development: Collaborate with global and regional regulatory teams to conduct thorough assessments for new business initiatives. Identify necessary adjustments to existing regulations and standards, the need for new regulations, and outline a strategic roadmap over multiple time horizons for market access, particularly for our innovative Functional Complements portfolio. This role will also work closely with cross-functional teams, including Marketing, Legal, R&D, and Supply Chain, to ensure alignment and effective execution of strategies. • Strategic Advocacy Support: Contribute to the global agenda on regulatory sciences and advocacy by defining Royal Canin's positions on critical regulatory topics, protecting existing business interests, while fostering growth opportunities for both current and new portfolios, especially on the Supplements category. Build and maintain relationships with key external stakeholders and represent Royal Canin in relevant global forums. • Communication and Material Development: Organize and synthesize complex scientific information to create clear and compelling written materials, especially to support regulatory sciences and advocacy efforts. This includes developing articles, presentations, and summary reports tailored to various audiences. What can you expect from Mars? • Work with diverse and talented Associates, all guided by the Five Principles. • Join a purpose-driven company, where we’re striving to build the world we want tomorrow, today. • Best-in-class learning and development support from day one, including access to our in-house Mars University. • An industry-competitive salary and benefits package, including a company bonus. Mars does not sponsor visas for this role. #LI-Hybrid #LI-AM1 Skills: Communication, Horizon Scanning, Identifying Opportunities, Policy and Regulation, Portfolio Management, Regulatory Intelligence, Regulatory Strategy Development, Stakeholder Engagement, Technical Writing Competencies: Action Oriented, Business Insight, Collaborates, Communicates Effectively, Strategic Mindset The base pay range for this position at commencement of employment is expected to be between the range listed below, however, base pay offered may vary depending on multiple individualized factors, including but not limited to, market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, if eligible, including variable pay, medical and dental benefits, participation in 401k plan, and paid time off benefits. Eligibility for these additional elements depend on the position offered and the employee’s work schedule (i.e., part-time schedule, store associate). Details of participation in these benefit plans will be provided if an applicant receives an offer of employment. USD 107,071.00 - USD 147,223.00

Do you want to be part of an organization that is making a difference in the lives of millions of people worldwide? If so, we want to hear from you! QPS, LLC has an opening for a Regulatory Affairs Supervisor! QPS’ Story: Since its inception, QPS has been assisting pharmaceutical, biotechnology and medical device companies with their drug development efforts by providing a full range of DMPK, Toxicology, Bioanalysis, Translational Medicine, Early Phase Clinical and Phase II – IV Clinical Research services. To meet the needs of our clients, we strive to employ talented, caring and committed individuals who will work collaboratively towards achieving our mission of improving human health and the quality of life. Team members enjoy challenging and rewarding work and are encouraged achieve their best. Underpinning the operation is a culture that values diversity, innovation, accountability, teamwork and a friendly atmosphere where performance is recognized and rewarded. We provide unique company benefits, training, and advancement opportunities. Most importantly, we value each of our team members as employees and as individuals. If this sounds like your ideal work environment, then we would love to speak with you, so apply today! Please visit our website ( www.qps.com ) for more information and to see all current openings. The Job As a Regulatory Affairs Supervisor with QPS (a Full-service, Global Contract Research Organization), You Will Lead Regulatory Strategies And Submission Activities For Sponsor Clients Across Both The United States (FDA) And Europe (EMA). You Will Manage Regulatory Deliverables Across Multiple Projects And Therapeutic Areas, Collaborating With Internal Teams And Sponsor Stakeholders To Ensure High-quality, Compliant Submissions That Meet Global Health Authority Requirements: • Serve as the primary regulatory lead on sponsor projects, advising on and implementing submission strategies for INDs, CTAs, NDAs, MAAs, and amendments/variations. • Manage and oversee the preparation, review, and timely submission of regulatory documents to the FDA, EMA, and other national competent authorities in Europe. • Participate in regulatory authority meetings (e.g., Pre-IND, Scientific Advice) and assist sponsors with briefing package development and logistical planning. • Provide expert guidance to internal teams and sponsor clients on ICH, FDA CFR, EU CTR, and EMA guidelines. • Collaborate cross-functionally with Clinical Operations, CMC, Pharmacovigilance, and Medical Writing to ensure cohesive submission content. • Supervise or mentor junior regulatory team members, reviewing their work for quality and consistency. • Maintain awareness of changes in global regulatory requirements and provide proactive communication to internal and external stakeholders. • Support business development by contributing to proposals, capabilities presentations, and bid defense meetings when regulatory input is required. Work Location This job will be 100% home-office based. (see Telecommuting Policy for full details) Requirements • Bachelor’s degree in life sciences, pharmacy, or related field (Advanced degree preferred). • 5–8 years of regulatory affairs experience, with at least 3 years in a CRO or client service environment. • Demonstrated experience with US FDA and EMA regulatory submissions (e.g., IND, NDA, CTA, MAA), including eCTD format. • In-depth knowledge of global regulatory frameworks, including ICH, GCP, EU Clinical Trial Regulation (CTR), and US FDA regulations. • Strong project management and communication skills, with the ability to manage multiple sponsor relationships and competing deadlines. • Experience leading regulatory meetings with clients and/or health authorities. • Proficiency with document management systems and submission platforms (e.g., Veeva Vault, GlobalSubmit, Extedo). • Regulatory Affairs Certification (RAC) or equivalent is a plus. • Preferred Experience includes: • Exposure to oncology, rare disease, or biologics development programs. • Experience supporting early-phase clinical trials through to registration. • Prior involvement in orphan drug designations, expedited programs (e.g., Fast Track, PRIME). • Comfortable working across time zones and in a fast-paced, deadline-driven CRO environment Why You Should Apply • Great learning opportunities, especially for those new to the field. Our seasoned professionals are here to support and work with you to explore your learning potential and career goals. • Structured Career Ladders that provide excellent growth based on your personal aspirations. • Bonuses and merit increases are a part of the QPS total rewards approach and are linked to individual, team and company performance. • Solid Benefits package, including Company-matched 401(k), and Company-sponsored Group Life/AD&D and Short and Long-term Disability Insurance • Park-like setting in Newark, Delaware • Internal committees designed with the needs and enjoyment of QPS employees in mind. QPS, LLC is an Equal Employment Opportunity/Affirmative Action Employer. In accordance with federal, state, and local laws, we recruit, hire, promote and evaluate all personnel without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, citizenship status, physical disability, protected veteran status, or any other characteristic protected by law. Job applicants and present employees are evaluated solely on ability, experience, and the requirements of the job. In addition, QPS, LLC is a federal contractor and desires priority referrals of protected veterans.

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: • Career development with an international company where you can grow the career you dream of. • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. • An excellent retirement savings plan with high employer contribution • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. The Opportunity This Regulatory Affairs Manager – International Compliance Operations will work on-site at our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. This Regulatory Affairs Manager – International Compliance Operations will provide support for the regulatory department to ensure efficient and compliant business processes and environment. This position has responsibility for compliance activities for products and processes. The individual may execute tasks and play a consultative role by partnering across business functions. This new team member assists in identifying emerging regulations, interpreting them and ensuring that they are effectively presented to different stakeholders across the organization. Recommends, interprets and implements companywide policies and procedures to accomplish assignments and resolves a broad range of issues and problems. Ensures employee compliance with such policies, practices and procedures and is responsible for continuous process improvement. Assures that quality of services meets internal and external customer requirements. What You’ll Work On • Assist in SOP development and review • Provide regulatory input to product lifecycle planning • Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions. • Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes. • Determine trade issues to anticipate regulatory obstacles. • Determine and communicate submission and approval requirements. • Participate in risk benefit analysis for regulatory compliance. • Assess the acceptability of documentation for gap assessments submitted. • Monitor impact of changing regulations on submission strategies. • Assess external communications relative to regulations. • Review regulatory aspects of contracts. • Assist with label development and review for compliance before release. • Contribute to the development and functioning of the crisis/ issue management program. • Provide regulatory input for product recalls and recall communications. • Maintains expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decision making; communicates such knowledge to all internal stakeholders. • Remains current on developments in field(s) of expertise, regulatory requirements, as well as industry trends and trains staff regarding changing regulations that affect regulatory submissions. Maintains knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences. • Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence. • Performs related functions and responsibilities, on occasion, as assigned. • Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions. • Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. • Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes. • Participate in risk benefit analysis for regulatory compliance. • Monitor impact of changing regulations on submission strategies. Required Qualifications • Bachelor’s degree or an equivalent combination of education and work experience • Minimum 8 years’ experience in the medical device industry, with 5 of those years related to the preparation of FDA submissions (PMA, IDE, 510(k)) for Class I, II, and III medical devices. • Ability to work effectively on project teams. • Strong organizational skills with the ability to juggle multiple and competing priorities. • Scientific writing experience is required. • Working knowledge of QSR, ISO, and EN standards. • Strong working knowledge of regulatory requirements for European community, Japan, Canada, and other countries. • Strong verbal and written communications with ability to effectively communicate and present at multiple levels in the organization. Preferred Qualifications • Bachelor’s degree in medical, science or engineering related discipline. • Advanced level degree • Experience with FDA, ANVISA, TGA, NMPA, EU and other international medical device / drugs / pharma regulations and submissions. • Experience with design controls in medical devices, IVDR, Pharma industries • Experience with Veeva Vault • Proficient with Excel and PowerPoint and presenting information to leadership • Previous experience working in a highly matrixed and geographically diverse business environment • Certification is a plus (such as PMP, RAC. LEAN.) Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. The base pay for this position is $112,000.00 – $224,000.00. In specific locations, the pay range may vary from the range posted.

Job Level: Technical Leadership-T2 Job Description: Are you passionate about shaping the future of pet nutrition and eager to make a meaningful impact? Join the Royal Canin Regulatory Affairs department as a pivotal member of the Global Market Access Strategy team. In this dynamic role, you will play a crucial part in ensuring our innovative portfolio can access markets seamlessly and in compliance with all relevant regulations. Your expertise will be instrumental in maximizing the potential of our innovations, particularly within the Pet Supplements business. You will be at the forefront of shaping the future regulatory environment, leveraging our Regulatory Sciences and Advocacy capabilities. By proactively anticipating how evolving regulations and standards will impact compliance criteria for products and claims, as well as technical & sanitary requirements for raw materials & products, you will navigate the complexities of the regulatory environment. Your insights will directly inform product design and manufacturing strategies, empowering us to promote our distinctiveness in the market with speed and agility. As we adapt to disruptive sciences and technologies, your role will be vital in creating new regulatory frameworks that support our innovations. What are we looking for? Minimum Requirements • Bachelor’s Degree (preferably in Biological Sciences, Nutrition, Biochemistry, Food Science, Animal Science, or related technical field) • 7+ years of professional experience, including 3 to 5 years specifically in Regulatory Affairs (and/or R&D roles closely aligned with regulatory and market access topics) within the food, feed, or pet food sectors; Animal/ Feed Supplement industry experience is a plus. • Regulatory expertise: in-depth knowledge of food product law, particularly in the US regulatory framework; familiarity with regulations in China and the EU is a plus. • A confident, action-oriented individual with strong communication skills, capable of effectively presenting information and collaborating across diverse organizational and cultural boundaries. • Proven ability to influence stakeholders and manage projects and portfolios, demonstrating strong problem-solving capabilities. • Fluent in English, any additional language is a plus (French, Chinese, German, or Spanish) • Up to 15% travel required (domestic/international) Preferred Qualifications • Advanced Degree in Biological Sciences, Nutrition, Biochemistry, Food Science, Animal Science, or related technical field What will be your key responsibilities? • Regulatory Strategy Development: Collaborate with global and regional regulatory teams to conduct thorough assessments for new business initiatives. Identify necessary adjustments to existing regulations and standards, the need for new regulations, and outline a strategic roadmap over multiple time horizons for market access, particularly for our innovative Functional Complements portfolio. This role will also work closely with cross-functional teams, including Marketing, Legal, R&D, and Supply Chain, to ensure alignment and effective execution of strategies. • Strategic Advocacy Support: Contribute to the global agenda on regulatory sciences and advocacy by defining Royal Canin's positions on critical regulatory topics, protecting existing business interests, while fostering growth opportunities for both current and new portfolios, especially on the Supplements category. Build and maintain relationships with key external stakeholders and represent Royal Canin in relevant global forums. • Communication and Material Development: Organize and synthesize complex scientific information to create clear and compelling written materials, especially to support regulatory sciences and advocacy efforts. This includes developing articles, presentations, and summary reports tailored to various audiences. What can you expect from Mars? • Work with diverse and talented Associates, all guided by the Five Principles. • Join a purpose-driven company, where we’re striving to build the world we want tomorrow, today. • Best-in-class learning and development support from day one, including access to our in-house Mars University. • An industry-competitive salary and benefits package, including a company bonus. Mars does not sponsor visas for this role. #LI-Hybrid #LI-AM1 Skills: Communication, Horizon Scanning, Identifying Opportunities, Policy and Regulation, Portfolio Management, Regulatory Intelligence, Regulatory Strategy Development, Stakeholder Engagement, Technical Writing Competencies: Action Oriented, Business Insight, Collaborates, Communicates Effectively, Strategic Mindset The base pay range for this position at commencement of employment is expected to be between the range listed below, however, base pay offered may vary depending on multiple individualized factors, including but not limited to, market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, if eligible, including variable pay, medical and dental benefits, participation in 401k plan, and paid time off benefits. Eligibility for these additional elements depend on the position offered and the employee’s work schedule (i.e., part-time schedule, store associate). Details of participation in these benefit plans will be provided if an applicant receives an offer of employment. USD 107,071.00 - USD 147,223.00

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. Apply now for the position of Regulatory Affairs Manager, and you will join our Ultrasound Diagnostic Imaging and become part of a dynamic global community of scientists, engineers, clinicians, developers, and professionals who are pushing the boundaries of what’s possible, to improve people’s lives around the world. In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more. You will work cross-functionally with R&D, Clinical, Marketing, Quality, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions. This is an onsite position in Issaquah, WA office. Remote option can be considered for exceptional candidates. Your Role: • Develop and implement global regulatory strategies for new product registrations, software updates (including AI-powered features) and product lifecycle management. • Lead preparation and submission of technical documentation and regulatory dossiers to authorities such as NMPA, FDA, EU notified bodies, and other international regulatory agencies. • Oversee and coach a team of regulatory professionals to support both strategic and operational objectives. • Interpret and apply regulatory requirements for medical devices (including IEC/ISO standards, NMPA, FDA 510(k), MDR, etc.). • Define and execute submission strategies to meet timelines and business goals. • Act as liaison to regulatory authorities and internal/external stakeholders; manage interactions and responses during submission review. • Monitor changes in international regulatory environments and communicate impacts to internal teams. • Represent the company in industry groups or regulatory associations, where appropriate. • Support training and knowledge-sharing on country-specific regulatory requirements within the organization. Your Expertise: • Expertise with global medical device regulations and registration processes, especially USA 510(k) and EU MDR. • Superior presentation skills when communicating with all levels of the organization, business partners, and external sources. • Knowledge of Artificial Intelligence and Machine Learning (AI/ML) Enabled Medical Devices is highly desired. • Experiences with diagnostic ultrasound and its clinical utilities, and Software as a Medical Device (SaMD) is preferred. • Ability to work with evolving technologies, systems, and global teams in a fast-paced, matrixed environment. Required Skills, Education and Experience for this position: • BS/MS degree or equivalent experience required. Related engineering, science, regulatory or medical disciplines preferred. • 8+ years of regulatory experience in medical device industry, preferably in diagnostic imaging with AI powered features. • Professional certifications, e.g., RAC or other quality and regulatory related certifications are a plus. • Strong organizational, negotiating, and problem-solving skills. • Excellent written and oral English communication skills. • Leadership and presentation skills. • Great judgment and confidence in resolving matters requiring management attention. • Ability to work independently in fast-paced environment and adapt to change. • Willing to travel up to 10%. • Flexibility is expected to participate in global team meetings. The pay range for this position is $133,900 - $200,900 annually; however, base pay offered may vary depending on job-related knowledge, skills, and experience. The annual incentive target is X% of base pay. Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay. Details regarding our benefits can be found here: https://benefitsatshs.com/index.html Equal Employment Opportunity Statement Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. EEO is the Law Applicants and employees are protected under Federal law from discrimination. To learn more, Click here. Reasonable Accommodations Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations. If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func@siemens-healthineers.com. Please note HR People Connect People Contact Center will not have visibility of your application or interview status. Pay Transparency Non-Discrimination Provision Siemens Healthineers follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here California Privacy Notice California residents have the right to receive additional notices about their personal information. To learn more, click here. Beware of Job Scams Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers Career Site. “Successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.” We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started. To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes. Who we are: We are a team of more than 73,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways. How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. To find out more about Siemens Healthineers businesses, please visit our company page here. The annual base pay for this position is: Min $133,900 - Max $200,900 Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate. If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance. The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time. Equal Employment Opportunity Statement: Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. EEO is the Law: Applicants and employees are protected under Federal law from discrimination. Reasonable Accommodations: Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations. If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func@siemens-healthineers.com. Please note HR People Connect People Contact Center will not have visibility of your application or interview status. California Privacy Notice: California residents have the right to receive additional notices about their personal information. To learn more, click here. Export Control: “A successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.” Data Privacy: We care about your data privacy (https://www.siemens-healthineers.com/careers/recruitment-application-privacy-notice) and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started. Beware of Job Scams: Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site. To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.

Payroll Title: CLIN RSCH SUPV 2 Department: CANCER CENTER/Clinical Trials Office Hiring Pay Scale $94,400 - $164,000 / Year Worksite: Moores Cancer Center Appointment Type: Career Appointment Percent: 100% Union: Uncovered Total Openings: 1 Work Schedule: Days, 8 hrs/day, Monday-Friday #134458 Manager, Regulatory Affairs - Hybrid Extended Review Date: Mon 6/9/2025 Apply Now UC San Diego values equity, diversity, and inclusion. If you are interested in being part of our team, possess the needed licensure and certifications, and feel that you have most of the qualifications and/or transferable skills for a job opening, we strongly encourage you to apply. This position will remain open until a successful candidate has been identified. Special Selection Applicants: Apply by 03/12/2025. Eligible Special Selection clients should contact their Disability Counselor for assistance. This position will work a hybrid schedule which includes a combination of working both onsite at Moores Cancer Center and remote. DESCRIPTION The Moores Cancer Center (MCC) is one of just 53 NCI-designated Comprehensive Cancer Centers in the United States and the only one in San Diego County. As a consortium cancer center, it is a collaborative partnership between the UCSD: encompassing 28 departments, 6 schools (School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, School of Public Health, Jacobs School of Engineering, School of Biological Sciences & the School of Physical Sciences), UCSD Health oncology hospitals and clinics; the basic and public health research and outreach of San Diego State University (SDSU), and the basic and translational research of the La Jolla Institute of Immunology (LJI). These various programs and units are all dedicated to fulfilling the Moores Cancer Center's mission of reducing cancer's burden. As such, it ranks among the top centers in the nation conducting the continuum of cancer research, providing advanced patient care, and serving the community through outreach and education programs. As a top-ranking, future-oriented organization, we offer challenging career opportunities in a fast-paced and innovative environment. Moores Cancer Center follows a progressive philosophy of career-path development for its employees includingopportunities for cross-training, professional development, and progressive responsibility. MCC's mission is to transform cancer care in our catchment area and beyond by driving exceptional scientific discoveries and innovations in prevention, detection, care, and training. MCC will make a global impact on improving health by reducing cancer burden through accelerated discovery and translation, compassionate and interdisciplinary care, education and community engagement, with the foundation of our core values - Excellence, Innovation and Risk-Taking, Collaboration, Diversity and Service. The Clinical Trials Office (CTO) at UCSD's Moores Cancer Center administers many clinical trials on behalf of its member investigators, including trials sponsored by National Cancer Institute cooperative groups, pharmaceutical companies, and physician investigators. Reporting directly to the Executive Administrative Director (EAD) of the Moores Cancer Center Clinical Trials Office (CTO), the Manager, Regulatory Affairs leads a team of Regulatory Coordinators while taking on more programmatic responsibilities. With a focus on program enhancement, the Regulatory Manager collaborates closely with training and education specialists to strengthen key regulatory practices for Regulatory Coordinators, Clinical Research Coordinators and Data Coordinators. This involves creating and maintaining standard operating procedures, written instructions, and templates to streamline and optimize regulatory processes. Acting as a crucial link between the MCC CTO and various stakeholders, the Regulatory Manager serves as a liaison with both the Institutional Review Board (local and commercial) and ancillary committees. The incumbent demonstrates expertise in regulatory matters, serving as a subject matter expert when engaging with sponsors and auditors. The scope of the incumbent's responsibilities extends to designing research projects of significant scale and complexity. Their extensive knowledge of clinical research protocols and processes enables them to lead these ambitious projects, contributing to the MCC CTO's overall success. Managing a team of highly skilled professionals in a matrixed organization, the Regulatory Manager ensures the achievement of the MCC CTO's activation targets and ongoing compliance with regulatory requirements for all active clinical trials under the CTO's purview. Provides direct supervision typically to professionals or skilled technical employees. Functions as advisor to unit and administration. Analyzes and resolves problems, interprets policies (e.g., fiscal management, HR, contracts and grants, resource management in defined areas) and demonstrates solid subject matter knowledge. Exercises judgment within defined procedures and policies to determine appropriate action. Supervises staff to assure accountability and stewardship of department resources (operational, financial, and human) in compliance with departmental goals and objectives. Lead the CTO Regulatory Affairs unit to support compliant study activation and management of active clinical trials managed by the CTO. Apply extensive knowledge of clinical research protocols and processes to design research projects of large scope and high degrees of complexity. Provide direction on programmatic efforts and developing systems to streamline regulatory processes in a compliant manner. Function as a lead in development of new processes and policies with project team for highly complex clinical trials, along with other UCSD teams / departments. Monitor, evaluate and coordinate data from multiple systems to recommend new actions / procedures from research analysis. Assess policies and processes to ensure the proposed project plan is compliant with applicable guidelines. Ensure reporting is consistent with external guidelines, university policies and regulations. Develop and inform regulatory personnel about research policies. Perform regulatory checks and develop checklists to confirm compliant clinical trial activation, and provide ongoing guidance to team members to streamline clinical trial activation processes in the realm of regulatory affairs. Knowledgeable and has experience working with e-Regulatory systems. MINIMUM QUALIFICATIONS • Nine years of related experience, education/training, OR a Bachelor’s degree in related area plus five years of related experience/training. • Clinical Trial Professional certification from a professional society within one year in position. • Broad knowledge of clinical or laboratory research and clinical research philosophy. Demonstrated ability to translate clinical research philosophy into business best practices in a trial setting. • Demonstrated project management skills. Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities. • Demonstrated experience managing people with a wide range of educational backgrounds and skills. Demonstrated management and conflict resolution skills to effectively lead and motivate others. Demonstrated experience in training others in the field of research. • Demonstrates good problem-solving and analytical skills. Creatively addresses complex or new problems. • Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator. Ability to influence and negotiate. • Excellent interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration. • Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs. Proven ability utilizing clinical trial management systems. • Skills to work collaboratively with other cross-functional teams. Ability to interface and collaborate with other members of an extended study team. Ability to influence / persuade. Proven ability to effectively coordinate and integrate programs with others in division, department, and organization. PREFERRED QUALIFICATIONS • Advanced degree. SPECIAL CONDITIONS • Employment is subject to a criminal background check. Pay Transparency Act Annual Full Pay Range: $94,400 - $176,800 (will be prorated if the appointment percentage is less than 100%) Hourly Equivalent: $45.21 - $84.67 Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position. The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable). Apply Now If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements. If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable. UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team! Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached. To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit UC San Diego Principles of Community. The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law. For the University of California’s Anti-Discrimination Policy, please visit: https://policy.ucop.edu/doc/1001004/Anti-Discrimination UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information. UC San Diego Health maintains a marijuana and drug free environment. Employees may be subject to drug screening.