Regulatory Affairs Project Manager

Principal Regulatory Affairs Project Manager - Medical Devices

Global medical device manufacturer | Hybrid (3 days onsite) | Regulatory Affairs

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.

• 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

• 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

Base:$130,000 - $150,000 | 15% Bonus | Up to 4 weeks PTO on top of National Holidays