FDA Regulatory Attorney – Class III IVD / Companion Diagnostics
Axiom Talent Platform(22 days ago)
About this role
An FDA Regulatory Attorney role supporting a Fortune 500 clinical laboratory, serving as the primary FDA-facing regulatory lead for Class III PMA in vitro diagnostic (IVD) and companion diagnostic products. The position works closely with cross-functional internal stakeholders and external partners to guide regulatory strategy across the product lifecycle. The role is offered through Axiom’s on-demand legal talent model, supporting client engagements primarily remotely with potential onsite needs depending on the client.
Required Skills
- FDA Regulation
- Regulatory Strategy
- PMA Submissions
- Modular PMA
- Companion Diagnostics
- IVD
- FDA Meetings
- CDRH Interaction
- Q-Sub Preparation
- Postmarket Compliance
+8 more
Qualifications
- J.D.
- Active Bar License
About Axiom Talent Platform
axiomlaw.comAxiom is a legal services provider that connects companies with on‑demand legal talent through a network of 14,000+ lawyers. It delivers flexible staffing and managed legal services—from contract lawyers and project teams to integrated, technology‑enabled legal operations—so in‑house teams can scale expertise, control costs, and meet compliance needs. Clients choose Axiom for experienced attorneys, flexible engagement models, and a platform approach that blends senior legal skills with operational and tech support.
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