FDA Regulatory Attorney – Class III IVD / Companion Diagnostics

Core responsibilities:

• Lead FDA regulatory strategy and execution for Class III PMA IVDs and companion diagnostics, including lifecycle PMA planning and post-approval changes.
• Own strategy, drafting, and management of Modular PMAs, full PMAs, PCCPs, Q-Subs, SIRs, and related submissions.
• Act as the main interface with FDA/CDRH: lead meetings, negotiate positions, and draft responses to FDA requests for additional information.
• Advise on pre- and post-approval requirements (quality systems, risk management, MDRs, labeling, and other post-market obligations).

This role enables the development and approval of critical medical diagnostic products through expert FDA regulatory navigation, potentially accelerating access to life-saving diagnostics and treatments.

Required qualifications:

• J.D. and active license to practice law in at least one U.S. jurisdiction.
• At least five years of in-house experience at a medical device or diagnostics company is preferred.
• Direct ownership of Class III PMA IVD and/or companion diagnostic submissions (strategy, drafting, and FDA interaction).
• Recent, hands-on experience with Modular PMAs, FDA Q-Subs, PCCPs, SIRs, and lifecycle PMA strategy.

Compensation starting at $150,000 with a highly competitive benefits package including health benefits, 401K, professional development resources, and learning programs. Axiom is recognized as a best place to work for LGBTQ+ Equality and is Mansfield certified for diversity in hiring.