Sr Manager, International Device Regulatory Affairs
Biogen · Remote
RegulatoryRemoteFull-time$138k–$185kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Senior Manager leading international regulatory strategy for high-risk implantable medical devices across Japan, China, and Latin America. Responsibilities include submissions management, regulator engagement, cross-functional collaboration, and compliance oversight to support market access and post-market activities.
What they're looking for
- Bachelor's degree; advanced degree preferred
- 7+ years regulatory affairs experience with Class III implantable medical devices
- 5+ years experience with combination product implantable medical devices
- Deep understanding of international medical device regulations in Japan, China, Latin America
- Proven leadership and mentorship capabilities
- Strong cross-functional collaboration experience in global settings
- Excellent communication and negotiation skills
What you'll be doing
- Lead regulatory strategy and execution for high-risk implantable device programs in target international markets
- Serve as regulatory lead for interactions with international regulators and certification bodies
- Manage product development support, design changes, and post-market surveillance regulatory oversight
- Monitor evolving international regulations and drive implementation of regulatory intelligence
- Mentor regulatory staff and support cross-functional teams on compliance and inspection readiness
Privacy & handoff
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