Regulatory Affairs Associate Director / Director

Are you a strategic thinker with deep expertise in regulatory compliance for medical devices? A leading international medical device innovator is looking for an experienced Regulatory Affairs Associate Director or Director to support the development and market access of life-changing technologies. This is a unique opportunity to shape global regulatory strategies, influence senior leadership, and ensure compliance across a growing product portfolio.

With a strong international footprint and a commitment to advancing patient outcomes through high-quality medical technologies, the organisation offers an environment where expertise is valued, and innovation is a shared goal. This role sits within the International Regulatory Affairs team and is key to maintaining global compliance and supporting future growth.

Your role as Regulatory Affairs Associate Director/Director:

• Act as the primary point of contact with health authorities and regulatory agencies, ensuring smooth communication and successful submissions.

• Lead regulatory planning and execution for global submissions, with a focus on the German market and beyond.

• Represent Regulatory Affairs in internal and external audits, regulatory inspections, and cross-functional meetings.

• Provide expert regulatory input to product development strategies and change assessments, working in close collaboration with senior leadership and the board.

• Oversee the performance and future growth of the Regulatory Affairs department, including strategic hiring plans.

• Drive alignment of regulatory objectives with overall business strategy, ensuring proactive compliance with evolving global regulations.

Experience and qualifications for the Regulatory Affairs Associate Director/Director role:

• Advanced degree (Master's or PhD) in Life Sciences or a related discipline.

• Proven experience engaging with health authorities, including BfArM.

• Strong background in regulatory affairs within medical device companies, with at least 6 years of relevant experience.

• Prior experience in medical imaging, AI, or software-based devices is essential.

• Demonstrated leadership experience, including managing direct reports or building teams, is highly preferred.

• Clear understanding of international regulatory frameworks and requirements, including CE marking and global market submissions.

Perks and benefits:

• Competitive contract-based compensation aligned with senior-level market standards.

• Opportunity to lead regulatory strategy for a globally recognised medical device organisation.

• Exposure to cutting-edge innovations in medical imaging and AI-driven technologies.

• High-impact role with visibility at senior leadership and board level.

• Flexible, hybrid working options based in Germany.

For immediate consideration, please apply directly with your CV.
Alternatively, reach out to learn more about similar Regulatory Affairs opportunities across the medical device sector.