FDA Regulatory Attorney - Class III IVD / Companion Diagnostics

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.

Key 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).
• 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.

Compensation:

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

About Axiom:

For over 25 years, Axiom has pioneered the alternative legal services industry, now serving more than 1,500 legal departments globally with our unique blend of world‑class legal talent and advanced AI tools, delivering innovative solutions ranging from that combine top‑tier talent withcutting‑edgetechnology. We tackle complex legal matters across 12 practice areas for clients ranging from Fortune 100 to SMBs, empowering our legal professionals to engage in meaningful work that advances their careers. Our Talent NPS score of +71% and ourClientNPS score of +64% highlight our commitment to excellence ( Reported scores were Axiom’s average for 2025 – the legal industry average NPS score is +35% ). Join our forward‑thinking community whereyou’llkeep your career dynamic and multi‑faceted, be part of a company that values agility, collaboration, and excellence, and love both the law and your life.

Learn more about life at Axiom .

Axiom is the global leader in high‑caliber, on‑demand legal talent. Covering North America, the UK, Europe, and APAC, we enable legal departments to drive efficiency and growth and meet the demands of today’s business landscape withbest in classalterativelegal services.

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