Our client is an established medical device company supporting manufacturers of medical devices and in-vitro diagnostics (IVDs) across Europe. As they continue to expand their Regulatory Affairs and Quality team, they are seeking an experienced Senior Regulatory Affairs / Quality Management Manager with strong expertise across FDA, EU MDR, Risk Management, and Post-Market Surveillance (PMS) to support a broad range of regulatory projects.

Please note: This is a primarily remote position based in Germany, offering a high degree of flexibility, with occasional travel to clients where required. Candidates must already be based in Germany, hold German residency, and speak fluent German, both written and spoken. Unfortunately, relocation support or visa sponsorship is not available.

The role

As a Senior Regulatory Affairs / Quality Management Manager, you will work closely with medical device and IVD manufacturers, supporting the implementation of complex regulatory requirements across a variety of products and development stages. You will analyse regulatory requirements, develop practical compliance strategies, and work directly with multidisciplinary customer teams to ensure successful regulatory submissions, quality management, and product lifecycle compliance.

This position offers significant autonomy, exposure to a wide variety of medical technologies, and the opportunity to work on both strategic and hands-on regulatory projects.

Key responsibilities

• Provide Regulatory Affairs and Quality Management expertise for medical device and IVD manufacturers.
• Support FDA and EU MDR compliance activities throughout the product lifecycle.
• Develop and implement regulatory strategies for international product registrations and approvals.
• Support Quality Management System (QMS) activities and regulatory compliance initiatives.
• Lead and support Risk Management activities in accordance with ISO 14971.
• Coordinate Post-Market Surveillance (PMS) and regulatory lifecycle management activities.
• Analyse customer requirements and develop practical regulatory and quality solutions.
• Collaborate closely with cross-functional teams to deliver regulatory projects successfully.

Required experience and qualifications

• Several years of experience within Regulatory Affairs, Quality Management, Risk Management, and Post-Market Surveillance for medical devices and/or IVDs.
• Strong knowledge of FDA regulations, EU MDR, and international regulatory approval processes.
• Experience working for a medical device manufacturer, consultancy, or Notified Body.
• Degree in a scientific or technical discipline such as Biomedical Engineering, Engineering, Pharmacy, Life Sciences, or similar.
• Excellent German and English communication skills, both written and spoken.
• Strong analytical and problem-solving skills with the ability to work independently.
• Interest in leveraging AI tools and new technologies within regulatory workflows is considered advantageous.

Your consultant

As a Recruitment Consultant at Aspire Life Sciences, Taylor Lyons specialises in technical and executive hiring across Medical Devices, Neurotechnology, AI, and DeepTech. Taylor partners with venture-backed startups, scale-ups, and global medical device organisations to identify exceptional talent across Regulatory Affairs, Quality, Clinical, Engineering, and leadership functions throughout Europe, North America, and Asia.