What are the responsibilities and job description for the Regulatory Affairs Project Manager position at ACE MedTech?
Principal Regulatory Affairs Project Manager - Medical Devices
Global medical device manufacturer | Hybrid (3 days onsite)
The role
Our client, a long-established global leader in medical devices, 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 devices and combination products 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).