Regulatory Affairs Manager, Biomaterials External Innovation

Johnson & Johnson MedTech; Raynham (MA); On-site; USD 117,000 - 201,000; Full time

Job summary

Johnson & Johnson MedTech seeks a Manager, Regulatory Affairs - Biomaterials External Innovation for its Orthopaedics team located in West Chester, PA or Raynham, MA. You will lead regulatory activities for biomaterials, biologics, and externally sourced innovations, guiding strategy, submissions, and lifecycle management to enable timely product development.

You will collaborate with R&D, Quality, Clinical, Medical Affairs, and Business Development, provide mentoring, lead due diligence, and

Qualifications

• Bachelor's degree in scientific/engineering discipline.
• 8+ years of regulatory experience in medical devices, biologics, or regulated healthcare.
• Specialized regulatory expertise in CMC and CGMP; BLA/IDE experience preferred.
• Experience developing and executing regulatory strategies and due diligence for external partnerships.
• Ability to lead cross-functional teams and communicate clearly with stakeholders.

Responsibilities

• Leads regulatory activities supporting development, submission, approval, and lifecycle management of biomaterials and medical devices.
• Develops risk-based regulatory strategies to enable timely development and commercialization.
• Prepares and maintains regulatory submissions and files (BLAs, IDEs, PMAs, 510(k)s, De Novo, etc.).
• Defines strategies for pipeline development, clinical programs, and global launch readiness.
• Partners with R&D, Quality, Clinical, Medical Affairs, and Business Development to evaluate opportunities and implement regulatory plans.

Skills

CMC/CGMP knowledge

Regulatory strategy

External partnerships

Cross-functional collaboration

Education

Bachelor's degree in science/engineering/pharma

Job description

Johnson & Johnson MedTech seeks a Manager, Regulatory Affairs - Biomaterials External Innovation for its Orthopaedics team located in West Chester, PA or Raynham, MA. You will lead regulatory activities for biomaterials, biologics, and externally sourced innovations, guiding strategy, submissions, and lifecycle management to enable timely product development.

You will collaborate with R&D, Quality, Clinical, Medical Affairs, and Business Development, provide mentoring, lead due diligence, and