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 ofClass III PMA IVD and/or companion diagnostic submissions(strategy drafting and FDA interaction).
• Recent hands-on experience withModular 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 theprimary 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 $00 peryearand for non-attorney roles is $ per year.Compensation decisions are based onvarious factors including but not limited to experience skills certifications location and business 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 1500 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 Axioms average for 2025 the legal industry average NPS score is 35%). Join our forward-thinking community whereyoullkeep your career dynamic and multi-faceted be part of a company that values agility collaboration and excellence andlove 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 todays business landscape withbest in classalterativelegal services.

Diversityis core to our values and we are proud to be an equal opportunity employer. Axiom ensures equal employment opportunity in recruitment and employment without discrimination or harassment on the basis of race color nationality national or ethnic origin religious creed or belief political opinion sex gender gender identity gender identity status pregnancy or maternity age disability alienage or citizenship status marital (or civil or other partnership recognized by law) status genetic predisposition or carrier status sexual orientation military service or any other characteristic protected by applicable law. Axiom prohibits and will not tolerate any such discrimination or harassment.

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Employment with Axiom may be contingent upon successful completion of a background check providing proof of identity andpossessingthe necessary legal authorization to tothe San Francisco Fair Chance Ordinance NY Fair Chance Act and Los Angeles Fair Chance Initiative we will consider for employment qualified applicants with arrest and conviction records.

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Required Experience:

IC