Stefan Menzl

Principal Consultant Regulatory Affairs

Stefan Menzl, PhD
Principal Consultant Regulatory Affairs

Stefan has a wealth of regulatory, quality, clinical and management experience through many years in the industry of the medical device field. Stefan is fully engaged in various EU-MDR projects.

Before joining Qserve, Stefan was Global VP Quality & Regulatory Affairs at Paul Hartmann AG. He started his career in R&D in a biotechnology start-up company. After 4 years, he entered the medical device regulatory field as a Regulatory Affairs specialist at Baxter’s Cardiovascular division in Germany. In the course of his employment there, he moved to the position of Manager Quality & Regulatory Europe. In 2000 he joined Edwards Lifesciences, the global market leader in heart valves, headquartered in Irvine, California, to become their Director Regulatory & Quality Europe. As part of his duties there, he was also Managing Director of Edwards Lifesciences Services GmbH.

In 2005 he moved to AMO, where he was Director Regulatory Affairs, Compliance and Clinical Research for the EMEA region. In 2011 when AMO was acquired by Abbott, he moved within AMO to a more strategic role as Director International Regulatory Affairs, representing the company at industry branch organizations in Brussels and Germany and managing an international regulatory team.
Stefan has a Master degree in Biology and a PhD in Biotechnology.

Stefan combines strong experience in quality, compliance and regulations with a pragmatic, result driven approach at both operational and strategic level.

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