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

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