Regulatory Affairs Manager

EPM Scientific is working with an innovative medical device company in the oncology diagnostics space. The organisation develops cutting-edge technologies to support the detection and analysis of cancer cells, enabling more personalised treatment pathways.

Role Overview

We are seeking a Regulatory Affairs Manager to lead regulatory activities across Europe and support international expansion. You will play a key role in ensuring compliance and driving approvals for novel diagnostic technologies.

Key Responsibilities

• Lead regulatory strategy and submissions (EU MDR and international markets)
• Manage and maintain CE marking and technical documentation
• Act as the primary contact for notified bodies and regulatory authorities
• Ensure compliance with relevant standards (e.g., ISO 13485, MDR, IVDR where applicable)
• Provide regulatory guidance to R&D and cross-functional teams
• Prepare and review documentation including clinical evaluations, risk management, and labeling
• Monitor regulatory developments and ensure ongoing compliance
• Support audits and inspections

Requirements

• Degree in Life Sciences, Engineering, or a related field
• 5+ years' experience in Regulatory Affairs within medical devices
• Strong knowledge of EU MDR (IVD experience is advantageous)
• Experience with CE marking and technical file preparation
• Understanding of clinical and post-market regulatory requirements
• Fluency in English (German is a plus)

What's On Offer

• Opportunity to join a fast-growing, innovation-driven MedTech company
• Exposure to cutting-edge oncology diagnostics technology
• Collaborative and dynamic work environment
• Competitive salary and career progression opportunities