FDA Regulatory Attorney – Class III IVD / Companion Diagnostics
Axiom Talent Platform
•$104,500 - $325,000•Hybrid
About The Position
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.
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.
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.
Benefits
- health, dental, and vision insurance
- paid holidays and PTO
- flexible work arrangements
- professional development opportunities and tools
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
