Mike Wallenstein Novartis Pharma AG

Mike holds the position as Global Head Regulatory Devices & Combination Products at Novartis Pharma AG in Basel since August 2022. Prior to this role, Mike had the position of Novartis Global Head MDR implementation and was overseeing all activities related to the EU MDR implementation for Medical Devices & Combination Products. Mike was functioning as Executive Director QA to oversee all compliance activities related to Medical Devices & Combination Products at Novartis globally. Mike joined Novartis in 2010 as Global Auditor in Group Compliance and Audit. He has over 25 years of experience in QA, R&D, and Manufacturing within the Medical Devices & Pharmaceutical Industry. Mike is member of several US and EU Expert Committees and Interest Groups on Combination Products and lecturer at the Universities of Zürich/CH, Lausanne/CH, Bern/CH, and Baltimore/US. Before joining Novartis, he was Head Global Audit Systems at Gambro Renal Care (today Baxter) and European Head Quality Systems & Audits at 3M. He studied Chemical Engineering and Plastic Technologies, in Münster, Germany.