Regulatory Affairs Manager, Europe

Genesis Medtech Group; España; On-site; PHP 1,200,000 - 1,800,000; Full time

Job summary

Genesis Medtech Group is seeking a Regulatory Affairs (RA) Manager for Europe to oversee market access and lifecycle management of surgical devices within the EU. Key responsibilities include managing CE certification, authoring technical documentation, and developing clinical evaluation reports. Ideal candidates will have a Bachelor's or Master's degree in a relevant field, at least 8 years of experience in Medical Device Regulatory Affairs, and fluency in English. This role entails collaboration with teams across multiple time zones.

Qualifications

• Minimum 8 years of experience in Medical Device Regulatory Affairs.
• At least 3 years of hands-on EU MDR experience.
• Expert knowledge of relevant ISO standards.

Responsibilities

• Lead the maintenance of CE certification and new product submissions.
• Author and maintain Technical Documentation following MDR requirements.
• Establish and manage relationships with Notified Bodies.
• Oversee the development of Clinical Evaluation Reports.
• Partner with clinical teams for Post-Market Clinical Follow-up plans.

Skills

Medical Device Regulatory Affairs

CE marking for Class III devices

ISO 13485

ISO 14971

Technical Writing

Collaboration across time zones

Fluency in English

Education

Bachelor’s or Master’s degree in Biomedical Science, Engineering, Life Sciences

Job description

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 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 stability
• Notified 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 audits
• Clinical 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 expectations

Requirements

• Bachelor’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 s
• Expert 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 US
• Fluency in English language