Description

We are seeking a highly accomplished FDA/PMA MD Expert to serve as the senior regulatory authority for our organization. This executive-level role will lead regulatory strategy and execution for FDA-regulated medical devices, including PMA and 510(k) submissions. This individual will act as the primary interface with FDA Medical Device divisions (CDRH) and provide strategic oversight for regulatory pathways impacting our PRP systems and related technologies. The ideal candidate thrives in a high-accountability, fast-paced environment where regulatory precision directly impacts commercialization timelines and company growth. Executive-Level Responsibilities include establishing company-wide regulatory strategy, directing all PMA and 510(k) submission activities, serving as the primary liaison with FDA Medical Device reviewers, leading pre-submission meetings, and ensuring ongoing compliance with FDA regulations.

Requirements

Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or related field (Master’s, RAC, JD, or advanced degree strongly preferred). 10+ years of progressive FDA Medical Device regulatory leadership experience. Demonstrated executive ownership of successful PMA approvals and 510(k) clearances. Extensive experience working directly with FDA Medical Device divisions (CDRH). Proven ability to navigate complex scientific and clinical discussions with FDA Medical Officers. Deep expertise in regulatory strategy for medical device commercialization. Experience presenting regulatory strategy to executive leadership, board members, and investors. Ability to operate independently with full accountability in a small, high-growth organization.

FDA/PMA MD / Executive Level Expert

Description

Requirements

Regenlab USA