Senior Quality & Regulatory Affairs Manager | Medical devices and IVDs | Germany

Aspire Life Sciences supported an established medical device company with its search for a Senior Regulatory Affairs / Quality Management Manager. The company worked with medical device and in vitro diagnostic (IVD) manufacturers across Europe on regulatory and quality projects.

The role combined regulatory strategy with hands-on delivery. It involved advising manufacturers on FDA and EU MDR requirements, developing international registration strategies, supporting quality management systems, and managing risk in line with ISO 14971. Post-market surveillance and ongoing product compliance were also central to the brief.

The search called for experience across Regulatory Affairs, Quality Management, risk management and post-market surveillance in medical devices or IVDs. The position was primarily remote, with occasional client travel, and required candidates to be based in Germany with fluent German and English.