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Axiom · 23 hours ago

FDA Regulatory Attorney – Class III IVD / Companion Diagnostics

United States

Full-time

Remote

Senior Level

$150K/yr - $150K/yr

5+ years exp

Axiom is a global leader in high-caliber, on-demand legal talent, and they are seeking an experienced FDA Regulatory Attorney with expertise in Class III PMA in vitro diagnostic and companion diagnostic products. The role involves leading FDA regulatory strategy, managing submissions, and collaborating with cross-functional teams to ensure compliance and alignment with regulatory goals.

ComplianceConsultingLaw EnforcementLegalProfessional Services

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

Qualification

FDA regulatory strategyClass III PMA IVDModular PMAsFDA Q-SubsPCCPsSIRsLifecycle PMA strategyFDA regulations knowledgeJ.D. degreeIn-house experienceCross-functional collaborationCommunication skills

Required

J.D. and active license to practice law in at least one U.S. jurisdiction

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

Proven ability to act as the primary FDA-facing regulatory lead, work cross-functionally, and communicate clearly with technical and business stakeholders