Regulatory Affairs Manager Africa

Regulatory Affairs Manager Africa is responsible for leading global regulatory monitoring through system implementation, ensuring prompt communication and action on updates. The role coordinates international regulatory strategy implementation, aligning with business goals and facilitating cross functional collaboration. The role has responsibilities including managing compliance with country specific product regulations, overseeing submissions, and fostering positive regulatory agency relationships. The role analyzes regulatory changes, provides strategic recommendations to senior management, guides product teams on compliance, utilizes metrics for continuous improvement, communicates updates internally, and enhances compliance processes based on best practices and regulatory shifts.

• Leads the process of staying updated on global and regional regulatory requirements for products by implementing monitoring systems ensuring all regulatory updates are accurately communicated and acted upon and integrating findings into regulatory strategies.

• Coordinates the implementation of global and regional regulatory strategies for international markets by working closely with cross functional teams, developing comprehensive plans, and ensuring that all regulatory activities align with the organization's strategic goals and meet local regulatory requirements.

• Ensures organizational compliance with country specific regulations for product registration and commercialization by managing the entire regulatory submission process, overseeing the review and approval of documentation, maintaining local establishment registrations, and addressing any issues or concerns promptly and effectively. Focus area will be all African countries (both direct and indirect).

• Coordinates relationships with regulatory agencies by maintaining regular communication, attending industry events, representing the organization in regulatory discussions and negotiations, and ensuring positive and productive interactions that facilitate smooth regulatory approvals.

• Tracks, interprets, and communicates changes in regulations across different countries by leveraging advanced analytical tools, assessing the potential impact on the organization, providing strategic recommendations and detailed reports to senior management, and updating regulatory strategies to ensure ongoing compliance.

• Offers expert guidance on regulatory strategy and requirements to product design teams for new products and solutions, supporting regulatory planning for new product introductions and changes, ensuring continuous compliance with both global and regional regulations throughout the product lifecycle.

• Utilizes metrics and key performance indicators to meticulously assess and continuously improve the performance of the Global Regulatory Affairs function, facilitating informed decision making, strategic action planning, and driving ongoing advancements that align with the organization's regulatory and business objectives.

• Coordinates local testing required to support regulatory submissions by ensuring that all necessary tests are conducted in compliance with local regulations, collaborating with internal teams to accurately document and submit testing data, and ensuring that submissions are complete and compliant.

• Communicates updates on global and regional regulatory requirements and changes to internal stakeholders, providing clear guidance on compliance implications, supporting strategic adjustments, and ensuring all relevant teams are informed and aligned with the latest regulatory expectations.

• Enhances regulatory compliance processes and procedures by identifying opportunities for improvement, implementing enhancements based on industry best practices and regulatory changes, and ensuring that all compliance processes remain effective, efficient, and aligned with both global and local standards.

• Supports stakeholders in the region with regulatory and compliance documentation for new product introductions, reviews marketing materials to ensure consistency with approved claims, intended use, and regulatory positioning, and ensures that all promotional content aligns with local regulatory standards.

• Liaises with the Post Market Surveillance team to ensure awareness of all communications with regulators, supports any required escalations related to regulatory issues, and contributes to maintaining compliance by providing necessary documentation and strategic insights.

This role is expected to take over Authorized Representative role in South Africa and be the main contact for SAPHRA and will report to PS&Q Region Leader META.

• Bachelor's / master's degree in business administration, Legal, Communications, Quality Management or equivalent.

• Minimum 5 years of experience with bachelor's degree in areas such as Regulatory Strategy, International Regulations, Medical Device Regulations, Product Development, Supply Chain, Quality Management or equivalent.

• Knowledge of the regulatory requirements for medical devices in South Africa and the technical documentation of the devices he/she represents.

• Ability to fulfill regulatory obligations, including post market surveillance, vigilance, and reporting of adverse events.

• RAPS RAC certification is a strong asset.

• Strong communication and operational skills.

The Company's approved Employment Equity Plan and Targets will be considered as part of the recruitment process. As an Equal Opportunities employer, we actively encourage and welcome people with various disabilities to apply. Only apply for this role if you are a South African Citizen by birth or Naturalization prior to the 27 April 1994.

This role is an office role. (Johannesburg)