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 Senior Manager of Quality & Regulatory Affairs to oversee compliance, guide product development, and strengthen their quality framework.

The role

In this position, you will lead regulatory and quality initiatives and ensure that medical AI software is developed, documented, and maintained to meet international regulatory standards, while helping to shape and enhance the company’s quality management system.

Key responsibilities

• Advise teams on regulatory requirements for medical software, including MDR and FDA standards.
• Collaborate with software developers to prepare technical documentation and regulatory submissions.
• Drive continuous improvement of the quality management system to align with ISO 13485.
• Define, implement, and monitor internal quality policies, processes, and performance metrics.
• Plan and execute internal audits, and support readiness for external inspections.
• Keep abreast of regulatory updates and assess their implications for products and processes.
• Foster a culture of compliance and quality awareness across the organisation.

Required experience and qualifications

• Master’s degree in Engineering, Computer Science, or a related discipline.
• Strong familiarity with software development lifecycles and documentation practices.
• Understanding of AI model principles and cybersecurity considerations for medical software.
• Proven track record in regulatory affairs and quality management within the MedTech software space.
• In-depth knowledge of ISO 13485, IEC 62304, MDR, and FDA regulations.
• Hands-on software development experience is an advantage but not essential.

Why this role?

• Be part of an international, fast-moving team where your contributions directly impact innovative healthcare solutions.
• Enjoy the flexibility of hybrid work while benefiting from the stability of an established company.
• Competitive salary and perks including bike leasing, sports programs, and public transport benefits.
• Participate in team celebrations and events that build a collaborative culture.

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 helps top-tier candidates find roles where they can drive compliance, innovation, and operational excellence.