Regulatory Affairs Manager, Biomaterials External Innovation

6029-MEDICAL DEVICE BUSINESS SERVICES, INC. Legal Entity; Raynham (MA); On-site; USD 117,000 - 201,000; Full time

Job summary

Johnson & Johnson is seeking a Manager, Regulatory Affairs – Biomaterials External Innovation to lead regulatory strategies for biomaterials and externally sourced innovation opportunities within Orthopaedics. The role focuses on CMC/CGMP expertise to support development, submissions, and lifecycle management in global markets.

You will partner with R&D, Quality, Clinical, and Business Development, guiding early-stage assessments and due diligence for external partnerships.

Qualifications

• Minimum bachelor’s degree in a scientific/engineering field is required.
• Minimum 8 years of relevant regulatory experience in medical devices/biologics/pharma.
• Experience with BLA and IDE development, submissions, and lifecycle support preferred.

Responsibilities

• Lead regulatory activities for biomaterials, biologics, and combination products.
• Develop and execute regulatory strategies for pipeline development and global launches.
• Prepare and maintain regulatory submissions (BLAs, IDEs, PMAs, 510(k)s) and related documentation.
• Collaborate with R&D, Quality, Clinical, Medical Affairs, and other functions.

Skills

Regulatory leadership

Regulatory strategy

CMC/CGMP knowledge

BLA/IDE submissions

Due diligence

Cross-functional collaboration

Regulatory communications

Coaching/mentoring

Education

Bachelor’s degree in science/engineering/pharmacy

Advanced degree preferred

Job description

Johnson & Johnson is seeking a Manager, Regulatory Affairs – Biomaterials External Innovation to lead regulatory strategies for biomaterials and externally sourced innovation opportunities within Orthopaedics. The role focuses on CMC/CGMP expertise to support development, submissions, and lifecycle management in global markets.

You will partner with R&D, Quality, Clinical, and Business Development, guiding early-stage assessments and due diligence for external partnerships.