Manager, Regulatory Affairs- Biomaterials

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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Job Function:
Regulatory Affairs Group. Job Sub Function:
Regulatory Affairs. Job Category:
People Leader. All Job Posting Locations:
Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of America.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems.

Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Learn more at

We are searching for the best talent for a Manager, Regulatory Affairs – Biomaterials External Innovation to join our Orthopaedics team located in West Chester, PA or Raynham, MA.

Purpose:

The Manager, Regulatory Affairs – Biomaterials External Innovation is responsible for developing and executing regulatory strategies for biomaterials, biologics, combination products, and externally sourced innovation opportunities. In partnership with cross-functional teams and external partners, this role provides early-stage regulatory guidance, supports due diligence and business development activities, and advances product development, clinical programs, submissions, approvals, launch readiness, and lifecycle management. The Manager will provide specialized expertise in Chemistry, Manufacturing, and Controls (CMC), Current Good Manufacturing Practice (CGMP), Biologics License Applications (BLA), and Investigational Device Exemptions (IDE) to support timely, compliant decision-making and commercialization in key markets.

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
Leads regulatory activities supporting the development, submission, approval, and lifecycle management of biomaterials, biologics, combination products, and medical devices before global regulatory authorities. Develops risk-based regulatory strategies to enable timely development and commercialization. Manages assigned Regulatory Affairs activities, establishes strategic priorities, and communicates regulatory objectives, risks, and recommendations to project teams and business leaders. Leads the preparation and maintenance of regulatory submissions and files, including BLAs, IDEs and IDE Supplements, PMAs and PMA Supplements, 510(k) s, De Novo requests, HDEs, annual reports, global change notifications, and technical documentation, as applicable to the assigned portfolio.

Defines…