Senior FDA Regulatory Attorney (Class III IVDs & CDx)

Axiom is seeking an experienced FDA Regulatory Attorney to serve as the primary FDA-facing regulatory lead for Class III PMA IVDs and companion diagnostics. You will drive strategy and execution for complex submissions, lifecycle management, and cross‑functional collaboration with BD, R&D, quality, and manufacturing teams. The role requires JD with an active US license and hands‑on experience in in‑house medical device/regulatory settings, including Modular PMAs, Q‑Subs, PCCPs, and SIRs.