Regulatory Affairs Manager, Biomaterials External Innovation

Brighter Signals; Raynham (MA); On-site; USD 117,000 - 201,000; Full time

Job summary

Johnson & Johnson’s Orthopaedics team seeks a Manager, Regulatory Affairs – Biomaterials External Innovation, to lead regulatory strategy for externally sourced biomaterials and externally sourced innovations in West Chester, PA or Raynham, MA. The role requires deep CMC/CGMP expertise, regulatory submissions, and cross-functional leadership.

You will collaborate with R&D, Quality, Clinical, and Business Development to advance pipeline programs, ensure compliance, and enable timely market

Qualifications

• Bachelor’s degree in a scientific, engineering, pharmacy, or related field.
• 8+ years in medical device, biologics, pharmaceutical, or regulated healthcare.
• Specialized regulatory expertise in CMC and CGMP; BLA/IDE experience preferred.
• Experience developing regulatory strategies aligned with business objectives.

Responsibilities

• Leads regulatory activities for biomaterials, biologics, and medical devices worldwide.
• Develops risk-based regulatory strategies to enable timely development and commercialization.
• Manages regulatory submissions including BLAs, IDEs, PMAs, 510(k)s and De Novo.
• Partners with R&D, Quality, Clinical, and other functions to drive strategy.

Skills

Regulatory strategy

CMC/CGMP expertise

Cross-functional leadership

External partnerships

Education

Bachelor's degree in a scientific, engineering, pharmacy, or related field

Advanced degree preferred

Job description

Johnson & Johnson’s Orthopaedics team seeks a Manager, Regulatory Affairs – Biomaterials External Innovation, to lead regulatory strategy for externally sourced biomaterials and externally sourced innovations in West Chester, PA or Raynham, MA. The role requires deep CMC/CGMP expertise, regulatory submissions, and cross-functional leadership.

You will collaborate with R&D, Quality, Clinical, and Business Development to advance pipeline programs, ensure compliance, and enable timely market