Regulatory Affairs Project Manager

Principal Regulatory Affairs Project Manager - Medical Devices Global medical device manufacturer | Hybrid (3 days onsite) | Regulatory Affairs The role Our client, a long-established global leader in medical devices and combination products, is hiring a senior regulatory project leader to own its highest-stakes programs. You'll lead cross-functional teams through global submissions, including 510(k)s, EU MDR technical files, and filings supporting partner drug programs, from first strategy call to post-market. What you'll do Lead regulatory strategy and execution for medical devices across global markets Get complex submissions out the door on time, and own the agency responses that follow Spot regulatory risk early and kill it before it kills a timeline Sit face-to-face with customers, partners, and regulators on pre-subs, audits, and change notifications Build better tools: dashboards, databases, and processes that make the whole RA team faster What you bring BS + 5 years (or MS + 3) in science or engineering, with real device and combination-product registration experience A track record of submissions that got approved and agency conversations that went well The ability to lead teams you don't manage: R&D, quality, clinical, manufacturing Fluency in the standards that matter: ISO 13485, ISO 14971, 21 CFR 820 Prefered: RAC or PMP, Class I/II registrations, post-market lifecycle experience (change controls, CAPAs, complaints). Base:$130,000 - $150,000 | 15% Bonus | Up to 4 weeks PTO on top of National Holidays #J-18808-Ljbffr