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 OverviewWe are seeking a Regulatory Affairs (RA) Manager for Europe 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 ResponsibilitiesMDR Strategy & Certification: Lead the maintenance of CE certification and new product submissions for Class IIb and Class III high-risk devices under Regulation (EU) 2017/745Technical Documentation (TD): Author and maintain Technical Documentation in accordance with MDR Annex II and III, ensuring robust data for sterilization validation, biocompatibility (ISO 10993), and shelf-life stabilityNotified Body (NB) Management: Establish and manage relationships with NBs (e.g., BSI, TÜV SÜD, DNV), including audit lifecycle management, response to technical queries, and oversight of CAPAs arising from NB auditsClinical Evaluation Reports (CER): Oversee the development of Clinical Evaluation Reports (CERs) in line with MDCG guidelines; ensure strong clinical evidence and state-of-the-art (SOTA) analysis for Class III devices (e.g., sutures and implants)Post-Market Oversight (PMS/PMCF): Partner with clinical teams to design and execute Post-Market Clinical Follow-up (PMCF) plans and author Periodic Safety Update Reports (PSURs) PRRC Collaboration: Collaborate with the Person Responsible for Regulatory Compliance (PRRC) to ensure compliance with Article 15 of the MDR EUDAMED & UDI: Manage data entry and maintenance across EUDAMED modules, including Actor Registration, UDI/Device Registration, and Vigilance reporting Technical Writing: Translate complex engineering and clinical data into clear, well-structured, and persuasive technical documentation aligned with NB expectationsRequirementsBachelor’s or Master’s degree in Biomedical Science, Engineering, Life Sciences, or a related field Minimum 8 years of experience in Medical Device Regulatory Affairs, including at least 3 years of hands-on EU MDR experience Proven track record of successful CE marking for Class III devices (implants or active devices), with experience with absorbable materials or energy-based surgical systems is a strong advantage sExpert knowledge of ISO 13485 (QMS), ISO 14971 (Risk Management), and relevant standards (e.g., ISO 11607 for packaging, ISO 11135/11137 for sterilization) Ability to collaborate across time zones with various functional teams in Singapore, China, and the USFluency in English languageAbout Genesis MedTechWE MAKE BETTER HEALTHCARE HAPPEN.This is our quest: to make quality healthcare more affordable and accessible. Headquartered in Singapore, Genesis MedTech shares a bold new world of value-based healthcare across surgical, cardiology and vascular interventional specialities.With an open platform that brings the best of medtech together from every corner of the globe, we disrupt the inefficiencies and fragmentation that keep quality healthcare out of reach for many. Genesis MedTech aims to become the most scalable, efficient and transparent business platform for the medtech industry. At Genesis MedTech, we are also actively growing our product portfolio through R&D and innovation, acquisitions, as well as partnerships with strategic startups.Website: https://www.genesismedtech.com/