FDA Regulatory Lead - Class III PMA IVDs & Diagnostics
Axiom
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 and lifecycle management in collaboration with cross-functional and partner teams. The successful candidate will own Modular PMAs, Q-Subs, PCCPs, SIRs, and related submissions, advise on post-market obligations, and coordinate with BD, R&D, quality, manufacturing, and legal #J-18808-Ljbffr Axiom
Vacancy posted 5 days ago
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