Senior Medical Devices Regulatory Strategist
7 days ago
We are seeking a seasoned Regulatory Affairs expert to lead our global regulatory strategy and delivery for medical devices.
This role involves authoring and reviewing regulatory submissions, interpreting device-specific requirements, and collaborating with cross-functional teams to ensure compliance and consistency across high-volume portfolios.
The ideal candidate will have a strong understanding of ISO 13485, ISO 14971, design control frameworks, and relevant market-specific regulations. They will also possess excellent communication, project planning, and leadership skills to mentor junior team members and drive process improvements.
- Bachelor's degree in biomedical engineering, regulatory affairs, life sciences, or related discipline.
- 5+ years of experience in Regulatory Affairs within a regulated industry (preferably medical devices).
- Proven experience leading or coordinating global regulatory submissions.
In this role, you will have the opportunity to work on system-level verification, biocompatibility, human factors, and labelling updates for high-volume products. You will also collaborate with Engineering and Quality to resolve submission blockers and maintain lifecycle documentation compliance.
Mentorship & Peer Enablement
You will mentor junior team members in regulatory interpretation, submission content quality, and cross-functional collaboration. You will also support onboarding and documentation standardization across the team.
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