FDA Regulatory Attorney - Class III IVD / Companion Diagnostics
External
Axiomtalentplatform · RemoteFull-timeRemote4mo ago
ClassificationRisk Management
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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.
Requirements
- 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.
Benefits
About Axiom: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 with best in class alterative legal services.Upon request and consistent with applicable laws, Axiom will provide reasonable accommodations for individuals with disabilities who require accommodations to participate in each stage of the recruitment process. To request an accommodation, please contact benefits@axiomlaw.com.Axiom respects your privacy. For an explanation of the kind of information we collect about you aHealth insuranceDental insuranceVision insurancePaid time offFlexible schedule
Additional Information
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.
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Company Intel
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