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, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, 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.Learn more at jnj.com

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We provide an inclusive work environment where each person is considered as an individual.

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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

Job Description:

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 https://www.jnj.com/medtech

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.

Responsibilities include:

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures a...