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