Manager, Regulatory Affairs- Biomaterials

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world 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 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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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 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 and executes regulatory strategies for pipeline development, clinical programs, and global launch readiness, with particular emphasis on Biomaterials External Innovation opportunities.
• Partners with R&D, Quality, Clinical, Medical Affairs, Supply Chain, Commercial, Business Development, and other cross-functional stakeholders to evaluate opportunities and implement regulatory strategies.
• Exercises independent judgment on complex regulatory issues, identifies key risks and evidence requirements, and drives execution of regulatory deliverables across assigned projects and external partnerships.
• Provides day-to-day leadership, coaching, and technical guidance to Regulatory Affairs colleagues and cross-functional project teams, as applicable.
• Develops and delivers training for cross-functional partners on current and emerging regulatory, CMC, CGMP, biologics, combination-product, and clinical investigation requirements.

· Responsible for ensuring aligned and coordinated contact and communication with global and regional/local regulatory agencies

· Ensures that company policies, procedures and practices are in compliance with appropriate regulatory requirements

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