FDA Reg Attorney - Class III IVD & Companion Dx

Axiom is seeking an experienced FDA Regulatory Attorney to serve as the primary FDA-facing regulatory lead for a Fortune 500 clinical laboratory client. You’ll drive strategy and execution for Class III PMA IVD and companion diagnostic submissions, collaborating with cross‑functional and partner teams to align regulatory and business goals. The role requires a JD with active US license and at least five years of in-house medical device or diagnostics experience, with hands-on PMA and Q-Sub