Regulatory Affairs Manager (Clinical Focus)

Axogen(1 month ago)

Tampa, FL, Florida, United StatesOnsiteFull TimeManager$110,585 - $138,231Regulatory Affairs

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.

View Original Listing

Required Skills

Regulatory Strategy
Regulatory Writing
Team Leadership
Project Management
Submission Management
Clinical Programs
Safety Assessment
Regulatory Intelligence
Vault RIM
Audit Support

+3 more

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.

Apply instantly with AI

Let ApplyBlast auto-apply to jobs like this for you. Save hours on applications and land your dream job faster.

More jobs at Axogen

Area Sales Manager - Long Island South

Axogen(1 day ago)

Clinical Data Specialist

Axogen(4 days ago)

Sales Representative - Richmond & Norfolk, VA

Axogen(4 days ago)

Sales Representative - Richmond & Norfolk, VA

Axogen(4 days ago)