Senior Regulatory Affairs Lead, Orthopedics MedTech

6029-MEDICAL DEVICE BUSINESS SERVICES, INC. Legal Entity; Warsaw (VA); Vor Ort; USD 79.000 - 128.000; Vollzeit

Zusammenfassung

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist to support DePuy Synthes Orthopaedics across multiple U.S. locations, including Warsaw, IN; Raynham, MA; and West Chester, PA.

The role focuses on IDE, 510(k), PMA, and Technical Documentation filings and ensures labeling and product information comply with global regulations. The ideal candidate has at least two years of regulatory affairs experience with medical devices, knowledge of FDA and EU MDR/MDD guidance, and a BA/BS

Qualifikationen

• Minimum of 2 years in regulatory affairs or medical devices
• Knowledge of U.S. FDA and EU MDR/MDD guidance
• BA/BS degree required; advanced degree preferred

Aufgaben

• Prepares regulatory documentation for IDE, 510(k), PMA, Technical Files and other submissions
• Review and approve labeling and product support information for compliance
• Support global registrations (Japan, China, Australia, NZ) requirements
• Maintain conformance with applicable laws and corporate policies

Kenntnisse

Regulatory affairs

FDA regulations

MDR/MDD knowledge

Technical documentation

Communication skills

Project management

Quality systems

Orthopedic implants knowledge

Ausbildung

BA/BS degree

Advanced degree preferred

Jobbeschreibung

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist to support DePuy Synthes Orthopaedics across multiple U.S. locations, including Warsaw, IN; Raynham, MA; and West Chester, PA.

The role focuses on IDE, 510(k), PMA, and Technical Documentation filings and ensures labeling and product information comply with global regulations. The ideal candidate has at least two years of regulatory affairs experience with medical devices, knowledge of FDA and EU MDR/MDD guidance, and a BA/BS