The Opportunity: EU MDR Expedition

We are looking for an experienced, hands-on Regulatory & Quality Manager to take ownership of critical strategic milestones.

Over the next 12 months, your primary mission would be to transition of our FDA-based technical files into full EU MDR-compliant documentation to unlock CE marking across our product portfolio.

Fair warning: This is a hands-on execution role, not a purely advisory one. You’ll be steering the ship and rowing at the same time.

Alongside the MDR marathon, you’ll drive continuous improvement across our Quality Management System (QMS) and product quality control processes, keeping our operational engine running like a Swiss watch. We will expand into many new countries, each with its own regulatory questions, and you will navigate the improvement and implementation of our processes.

What You’ll Actually Do (Key Responsibilities) Lead the charge in converting FDA-based technical files into EU MDR-co...