Regulatory Affairs Manager
Zimmer Biomet · San Diego, CA
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Role summary
Zimmer Biomet seeks a Regulatory Affairs Manager to develop and execute regulatory strategies for medical devices while ensuring FDA and international compliance. The role serves as primary liaison with regulatory authorities and cross-functional teams throughout the product lifecycle.
What they're looking for
- Bachelor's degree in relevant discipline
- Minimum 8 years medical device regulatory affairs experience
- International regulatory experience required
- In-depth knowledge of FDA regulations (21 CFR Part 820) and ISO 13485
- Experience with 510(k), CE mark, and international submissions
- Strong project management and cross-functional leadership skills
- Regulatory Affairs Certification (RAC) preferred
What you'll be doing
- Author and submit U.S. and global regulatory filings including 510(k)s, IDEs, and EU technical documentation
- Maintain and update regulatory SOPs and work instructions aligned with current regulations and guidance
- Monitor evolving regulations and drive implementation of required changes across product design and QMS
- Serve as primary liaison with FDA, notified bodies, and other regulatory authorities for approvals and registrations
- Establish and manage Post-Market Surveillance and Post-Market Clinical Follow-Up activities in compliance with global requirements
Privacy & handoff
This role links to Zimmer Biomet's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.