Regulatory Affairs Manager Job at Katalyst HealthCares & Life Sciences, San Francisco, CA

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  • Katalyst HealthCares & Life Sciences
  • San Francisco, CA

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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