Senior Regulatory Affairs Specialist

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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Regulatory Affairs Group

Regulatory Product Submissions and Registration

Professional

Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America

About Orthopaedics

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

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

We are searching for the best talent for Senior Regulatory Affairs Specialist in Warsaw, IN, West Chester, PA , Raynham, MA.

The Senior Regulatory Affairs Specialist is responsible for regulatory activities to support new, modified and currently marketed medical devices in the DePuy Joint Reconstruction portfolio. This includes the preparation of regulatory documentation for submission to regulatory authorities (e.g., IDE, 510(k), PMA, Design Dossiers, and Technical Documentation) or internal regulatory assessment documentation. The Regulatory Project Leader is also responsible for the review and approval of all device labeling and product support information used in the promotion and educational activities of DePuy Synthes products for compliance to global regulations and company policies and procedures.

In conjunction with other functions they support post market and provide lead external and Internal audits.

• Prepares regulatory documentation for DePuy devices, including IDE, 510(k), PMA,…