Regulatory Affairs Lead - Medical Devices

CLIENT CANNOT SPONSOR/TRANSFER ANY CURRENT OR FUTURE WORK VISA

We're seeking a senior regulatory leader to own FDA strategy and execution for our client's medical device portfolio. This role serves as the primary interface with CDRH and leads all PMA and 510(k) activities, from early development through approval. You'll operate as the company's top regulatory authority-guiding strategy, managing risk, and ensuring regulatory decisions support commercialization and growth. Key Responsibilities Own regulatory strategy for Class

II & III

medical devices Lead all PMA and 510(k) submissions end-to-end Serve as primary liaison with FDA (CDRH, Medical Officers, leadership) Drive pre-sub meetings, deficiency responses, advisory panels, and post-approval commitments Advise leadership on regulatory risk, timelines, and clinical data requirements Align regulatory plans with clinical, quality, manufacturing, and commercial goals Ensure compliance with FDA regulations (21 CFR 803, 806, 807, 814, 820) Lead audit, inspection, and due diligence readiness Build scalable regulatory infrastructure to support growth