Team Lead Regulatory Affairs

Our client is an AI software medical device company based in Munich, developing next-generation medical imaging solutions. They are entering a growth phase and are looking for a Team Lead Regulatory Affairs to drive regulatory strategy, support product development, and lead regulatory activities across the business.

The role

In this position, you will lead regulatory initiatives and act as the key regulatory subject matter expert. You will ensure medical AI software is developed, documented, and maintained in line with global regulatory requirements, while guiding and mentoring regulatory team members and supporting cross-functional teams.

Key responsibilities

• Lead regulatory strategy and execution for medical software products across key markets.
• Advise internal teams on regulatory requirements for medical software, including MDR and FDA standards.
• Collaborate with software developers and product teams to prepare technical documentation and regulatory submissions.
• Support and guide regulatory team members, helping prioritise workload and ensure high-quality deliverables.
• Contribute to the continuous improvement of regulatory processes and alignment with the quality management system (ISO 13485).
• Support audit and inspection readiness activities from a regulatory perspective.
• Monitor global regulatory updates and assess their impact on products, strategy, and submissions.
• Promote regulatory awareness and compliance culture across the organisation.

Required experience and qualifications

• Master’s degree in Engineering, Computer Science, Life Sciences, or a related discipline.
• Strong understanding of software development lifecycles and documentation practices.
• Understanding of AI model principles and cybersecurity considerations for medical software.
• Proven experience in regulatory affairs within the MedTech software or SaMD space.
• Strong knowledge of MDR, FDA regulations, IEC 62304, and ISO 13485.
• Previous experience mentoring, coordinating, or leading regulatory activities or team members is highly desirable.
• Hands-on software development experience is an advantage.

Why this role?

• Be part of an international, fast-moving team where your work directly supports innovative healthcare technologies.
• Hybrid working environment combining flexibility with strong team collaboration.
• Competitive salary and benefits including bike leasing, sports programs, and public transport support.
• Collaborative culture with regular team events and celebrations.

Your consultant

As a Recruitment Consultant at Aspire Life Sciences, Taylor Lyons focuses on connecting senior Quality and Regulatory Affairs professionals with innovative MedTech companies across Europe and the US. Taylor supports top-tier candidates in securing roles where they can drive compliance, innovation, and operational excellence.