Senior Regulatory Affairs Specialist

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

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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 https://www.jnj.com/medtech

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, Technical Files, Design Dossier, and Technical Documentation files for submission to regional Health authorities per FDA, MDD and MDR requirements. This includes the resolution of regulatory issues and questions from regulatory agencies during the pre-market product development phase.
• Provides support in preparation, writing and submission of global registration activities (Japan, China, Australia, NZ) requirements.
• Incumbent knows, understands, incorporates and follows all applicable laws and regulations relating to DePuy Synthes business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
• Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
• Review and approve changes with Product Lifecycle Management System to devices, design, packaging and labelling for Notified Body, FDA, and Global impact
• Review product labeling and product support information for currently marketed products to ensure that product information and claims are consistent with premarket clearances and approvals and in compliance with relevant regulations and guidance.
• Maintain current knowledge to ensure compliance to the applicable regulatory and corporate standards/requirements (FDA Quality System Regulations, European Quality Standards and presiding Medical Device Regulation, ISO 13485, previous MDD, etc.).
• Perform other duties as assigned.

• Minimum of 2 years plus prior relevant regulatory affairs or experience in medical devices, preferred
• A minimum of 2 years plus medical device industry experience or relevant medical device experience
• Knowledge or Familiarity of U.S. FDA and EU Medical Device Regulations MDR (and previous MDD) and presiding guidance’s and standards a plus
• Knowledge of orthopedic implants a plus
• Familiarity with electronic submission preparation a plus
• Excellent written and oral communication skills
• Ability to handle multiple tasks, self-motivate and be detail oriented

BA/BS Degree required; advanced degree or equivalent work experience preferred

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