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Mike WallensteinGlobal Head Novartis MDR Implementation, External Engagement & DD&C Compliance at Novartis Pharma AG
Mike Wallenstein holds the position as Global Head Novartis MDR Implementation, External Engagement & DD&C Compliance at Novartis Pharma AG since April 2019. In this role, Mike oversees all activities related to the EU MDR implementation for Medical Devices & Combination Products at Novartis globally.
Prior to this position 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 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.