Regulatory Affairs Manager (Clinical Focus)

Axogen

3 months ago

3.2 on Glassdoor

Tampa, FL

Onsite

Full Time

Manager

2 applicants

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About this role

The Regulatory Affairs Manager (Clinical Focus) at Axogen leads regulatory efforts to support clinical development programs and ensure compliance with applicable domestic and international regulations and guidance. The role provides strategic oversight for clinical regulatory activities, supports regulatory submissions and readiness, and contributes to regulatory intelligence and safety assessments. This position is part of the Regulatory Affairs department and includes management of regulatory staff and participation in regulatory interactions and inspections.

Skills

Qualifications

Bachelor's Degree

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.