Geschäftsführer Qserve Deutschland l Regulatory Affairs Expert
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.
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."
Stefan has a Master degree in Biology and a PhD in Biotechnology.
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, to become their Director Regulatory & Quality Europe. 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 Director International Regulatory Affairs, representing the company at industry branch organizations in Brussels and Germany and managing an international regulatory team. At Paul Hartmann AG, Stefan was Global VP Quality & Regulatory Affairs.
The key expertise areas of Stefan:
- EU MDR, EU MDD
- Clinical Evaluation
- Global Regulation
- Risk Management
- Audits & Inspections
- Gap analysis
- Due Diligence
- Re-organization, Integration after Acquisition
Learn more about our services within Regulatory Affairs