Regulatory Affairs Manager, Europe

At Genesis MedTech, our quest is to make quality healthcare accessible for everyone. We believe each of us can make a positive impact at work. Together we explore ideas, innovate new solutions and make great things happen. Our culture is built on collaboration and a shared commitment to make an impact on the lives of our patients.

Position Overview

We are seeking a Regulatory Affairs (RA) Manager forEurope to ensure market access and lifecycle management of the company’s surgical portfolio within the European Union. This role serves as the primary liaison with Notified Bodies (NBs), translating R&D outputs into MDR-compliant technical documentation and ensuring ongoing compliance within the EUDAMED framework.

Key Responsibilities

• MDR Strategy & Certification: Lead the maintenance of CE certification and new product submissions for Class IIb and Class III high-risk devices under Regulation (EU) 2017/745
• Technical Docum...