Senior Quality & Regulatory Manager

Aspire Life Sciences supported a Munich-based medical AI software company as it searched for a Senior Manager of Quality & Regulatory Affairs during a period of growth. The position called for someone who could oversee regulatory compliance while strengthening the quality framework behind its medical imaging solutions.

The brief combined regulatory strategy with hands-on quality management. It covered EU MDR and FDA requirements, technical documentation and regulatory submissions, and the continued development of a quality management system aligned with ISO 13485. The role also involved working closely with software teams, planning internal audits and preparing for external inspections.

The search required experience in MedTech software, knowledge of IEC 62304 and an understanding of how AI models and cybersecurity considerations affect medical device development.

Taylor Lyons led the search as part of his work connecting Quality and Regulatory Affairs professionals with MedTech companies across Europe and the US.