Job Overview
The Regulatory Program Manager is a medical device project management role responsible for planning, coordinating, and driving cross-functional programs that initially support FDA 510(k) submissions for new and modified products, with future responsibility for helping define and prepare additional regulatory pathways such as CE Mark and other international approvals. This role owns program structure, timeline management, risk tracking, cross-functional alignment, and documentation readiness across product development activities, while partnering closely with Regulatory Affairs, Quality, Clinical, R&D, and Operations. The role is not the final regulatory signatory; instead, it ensures teams generate the inputs, design control outputs, and submission-ready documentation required for Regulatory Affairs to compile, submit, and defend filings.
Responsibilities
Experience
Pay: $150,000.00 - $180,000.00 per year
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Work Location: In person
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