[Hiring] FDA Regulatory Attorney @Axiom Talent Platform

Role Description

We are seeking an experienced FDA Regulatory Attorney with deep, hands-on expertise in Class III PMA in vitro diagnostic (IVD) and companion diagnostic products to work with our client, a Fortune 500 clinical laboratory. This person will serve as the primary FDA-facing regulatory lead, driving strategy and execution for complex submissions and lifecycle management in close partnership with cross-functional and partner teams.

• 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).
• Support product classification and premarket strategies for 510(k)-regulated IVDs, including Q-Sub preparation.
• Partner with cross-functional teams (BD, commercial, R&D, quality, manufacturing, legal, regulatory) and external partners to align regulatory and business goals.
• Develop and deliver training on FDA regulation of medical devices and IVDs, including approvals/clearances and enforcement topics.

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.
• Strong knowledge of FDA regulations and guidance for Class III PMA devices, IVDs, and companion diagnostics; familiarity with 510(k) pathways for IVDs preferred.
• Proven ability to act as the primary FDA-facing regulatory lead, work cross-functionally, and communicate clearly with technical and business stakeholders.

Requirements

• Compensation: The estimated total compensation for full-time Axiom attorney roles is $104,500-325,000 per year and for non-attorney roles is $71,250-309,750 per year.
• Compensation decisions are based on various factors, including, but not limited to, experience, skills, certifications, location, and business needs.
• Employees may be eligible for additional benefits, including health, dental, and vision insurance; paid holidays and PTO; flexible work arrangements; and professional development opportunities and tools.