Regulatory Affairs ManagerKatalyst Healthcares & Life Sciences • San Francisco, CA, US
Regulatory Affairs Manager
Katalyst Healthcares & Life Sciences • San Francisco, CA, US
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]
Job Title
Develop and execute U.S. regulatory strategies to support product submissions (e.g., IDE, 510(k), De Novo) and post-market requirements. Serve as the primary point of contact with the U.S. Food and Drug Administration (FDA) and their regulatory agencies, leading meetings, Q-Subs, and communications. Collaborate with cross-functional teams (R&D, Clinical,...
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Regulatory Affairs Manager • San Francisco, CA, US
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