Senior Regulatory Affairs Specialist, Program Lead
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About The Position
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. The Senior Regulatory Affairs Specialist, Program Lead will author regulatory submissions and support product development stages to help the organization achieve US and international regulatory (NPD) approval goals. This role involves managing, preparing, and submitting regulatory submissions required for device approvals and registrations in the US and globally, overseeing SME resources preparation of submission deliverables, and conducting regulatory evaluations of changes to Auris devices.
