Regulatory Affairs Leader
We seek a strategic visionary to lead regulatory affairs and drive product success globally.
About the Role:
* Leverage expertise in global regulatory strategies to support product development, commercialization, and market expansion.
* Oversee all regulatory submissions (CE marking, FDA 510(k)/PMA, and other global submissions) ensuring alignment with commercial and operational timelines.
* Serve as primary liaison with regulatory authorities, representing the company in all regulatory interactions and negotiations.
* Build and lead a high-performing regulatory team supporting early-stage product development and later-stage market access activities.
* Maintain proactive compliance across multiple geographies by monitoring and interpreting evolving regulatory requirements.
* Collaborate closely with cross-functional teams including R&D, Quality, Clinical, and Commercial to integrate regulatory requirements into project plans and strategic decision-making.
* Support due diligence and partnership activities through regulatory assessments and strategy development.
Requirements:
* Minimum 10 years experience in Regulatory Affairs within the medical device industry, with at least 3 years in a leadership role.
* Proven success in preparing and leading regulatory submissions for Class II/III devices (EU MDR and FDA pathways essential).
* Strong understanding of the global regulatory environment, including emerging markets.
* Ability to think strategically while executing detailed regulatory plans.
* Exceptional leadership, communication, and stakeholder management skills.
* Comfortable operating in a fast-paced, high-growth, entrepreneurial environment.
* Degree in Life Sciences, Engineering, Regulatory Affairs, or a related technical field; Regulatory Affairs Certification (RAC) is advantageous.