Regulatory Affairs Manager, New Product Development

Axogen(8 hours ago)

United States, Tampa, FloridaOnsiteFull TimeManager$113,903 - $142,378Regulatory Affairs

About this role

The Regulatory Affairs Manager, New Product Development at Axogen serves as the primary regulatory lead for early‑stage and full‑lifecycle development of new medical products, ensuring alignment with global standards and the company’s mission to improve peripheral nerve restoration. The role works closely with cross‑functional teams to enable successful market introductions and supports regulatory interactions for targeted markets. Position is based in Tampa, FL.

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Required Skills

Regulatory Strategy
Regulatory Submissions
Design Controls
Risk Management
Project Management
Regulatory Writing
Clinical Evidence
Labeling
Human Factors
Verification Validation

About Axogen

axogeninc.com

Axogen is a medical technology company focused on advancing peripheral nerve repair, describing its mission as "revolutionizing the science of nerve repair." With more than a decade of experience, it offers a comprehensive portfolio of surgical solutions used primarily by hand, reconstructive plastic, and oral/maxillofacial surgeons to treat a wide range of nerve injuries and help restore sensation and function. The company pairs biologic and engineered products with clinical education and surgeon support to improve patient outcomes and recovery.