Director of Regulatory Affairs

We are seeking a hands‑on Director of Regulatory Affairs to lead global regulatory strategy for a Class II medical device company. This role will own 510(k) strategy, agency engagement, and submission execution in a growing, innovation‑driven company. Their portfolio consists primarily of Class II devices, with potential incorporation of software or AI components.

• Develop and execute U.S. and global regulatory strategies for Class II medical devices.
• Lead preparation and submission of:
• Traditional, Special, and Abbreviated 510(k) submissions
• De Novo submissions (as applicable)
• EU MDR Technical Documentation (Class IIa/IIb)
• Serve as primary regulatory contact with the U.S. FDA and EU Notified Bodies.
• Determine product classifications, predicate strategy, and regulatory pathways.
• Guide labeling, claims development, and promotional review for compliance.

• Partner with R&D, Clinical, and Operations to integrate regulatory requirements into development plans.
• Provide regulatory input on verification & validation strategy.
• Advise executive leadership on regulatory risk, timelines, and global market access strategy.
• Support regulatory due diligence for investors and strategic partners.

• Lead regulatory strategy for product modifications and new indications.
• Ensure compliance with MDR reporting and vigilance requirements to the FDA and global authorities.
• Monitor evolving regulations and assess impact on marketed products.

• 10+ years of medical device regulatory experience.
• Demonstrated leadership of multiple successful 510(k) submissions.
• Strong knowledge of U.S. and international regulatory frameworks for Class II devices.
• Direct interaction experience with the US FDA.
• Experience in a small or growth‑stage medical device company.

• Experience with devices incorporating software components.