Regulatory Affairs Manager (Clinical Focus)

Axogen(1 month ago)

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

About this role

The Regulatory Affairs Manager (Clinical Focus) leads development and implementation of domestic and international regulatory strategies for Axogen’s clinical programs, ensuring compliance with applicable regulations and guidance. The role supports and drives regulatory submissions, oversees safety assessments and regulatory intelligence, and supervises Regulatory Specialists and Interns. The manager also coordinates cross-functionally with clinical, pharmacovigilance, and operations teams and participates in regulatory inspections.

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Required Skills

Regulatory Strategy
Regulatory Submissions
Regulatory Writing
Clinical Programs
Project Management
Leadership
Regulatory Intelligence
Safety Assessment
eCTD Management
Vault RIM

+5 more

Qualifications

Bachelor's Degree (Scientific/Regulatory/Health Preferred)

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.