Axiom

FDA Regulatory Attorney – Class III IVD, Companion Diagnostics

Axiom

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $150,000 per year

About the role

  • 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
  • health benefits
  • 401K
  • access to professional development resources
  • learning and development programs

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
FDA regulatory strategyClass III PMAModular PMAsPCCPsQ-SubsSIRsquality systemsrisk management510(k) pathwaysmedical device regulations
Soft skills
negotiationcommunicationcross-functional collaborationtraining developmentstakeholder engagement
Certifications
J.D.active law license