at J&J Family of Companies in Boise, Idaho, United States

Senior Regulatory Affairs Program Lead (Ethicon) - Medical Device Business Services, Inc. - 2406176450W

Description

Ethicon, Inc., part of the Johnson & Johnson MedTech family of companies, is currently recruiting for a Senior Regulatory Affairs Program Lead to support our Surgery business. The preferred location for this role is within a commutable distance of Raritan, NJ or Cincinnati, OH but remote options will be considered on a case by case basis.

About Johnson & Johnson

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 https://www.jnj.com/.

The MedTech Surgery Senior Regulatory Program Lead will be a responsible member of a Regulatory Affairs Team dedicated to developing and evaluating regulatory strategy in partnership with the assigned regulatory and clinical project leads. This individual will also be responsible for development of the programs and tools within MedTech ensuring successful execution.

This individual will provide active scientific contribution to clinical scientific discussions intended for regulatory agencies submissions and interactions which may include proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, and strategy development. Contribute to the development and delivery of appropriate Global EGS (Evidence Generation Strategies) and EDS (Evidence Dissemination Strategies) to support New Product Development and Life-Cycle Management, with collaborative relationships with all relevant Clinical, R&D and Regulatory partners ensuring cross-functional alignment.

This role will involve extensive team matrix interactions with colleagues from several different disciplines. This individual may be asked to contribute to the evaluation of scientific opportunities in the therapeutic area within the Franchise. Successful candidates will be forward thinking, anticipate needs and be able to work well in a fast-paced environment, either independently or as part of a collaborative team.

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