Stefan Menzl

Regulatory Affairs Expert

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 one of Qserve's trainers and he 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. He also 

Stefan about working at Qserve: 

"I am deeply impressed not only about the level of knowledge and expertise the people here at Qserve have, but also the team-spirit. Each and every one is fully engaged in the work of the team and does not sit passively on the sidelines. They’re willing to share information, knowledge, and experience and you can count on him or her to deliver good performance all the time. I am equally impressed about how people who speak up and express their thoughts and ideas clearly, directly, honestly, and with respect for others and for the work of the team. This makes Qserve a great place to work."

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