Michael Kuehler
Regulatory Affairs Senior Expert Medical Devices @Bayer
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WORK HISTORY
Regulatory Affairs Senior Expert Medical Devices @Bayer
Berlin, DE
Leadership role focusing on cross product and technology strategical and operational topics in global Regulatory Affairs with focus on Medical Devices and Drug-Device Combinations • Guide and coach teams to generate the outcomes on the mission, facilitate connection and collaboration• Set up regulatory medical device processes• Provide regulatory project support for the development and submission of medical devices and drug-device combination products including Notified Body Opinions• Drive internal and external collaboration (e.g. EFPIA) across the organization• Contribute as a member of governance bodies for the development of medical device and drug-device combination products
EDUCATION
ESMT Berlin
Management excellence company program
Technische Universität Berlin
PhD, medical engineering
FernUniversität in Hagen
Certificate, Business administration compact seminar
Technische Universität Berlin
Graduate Engineer, Medical Engineering
SKILLS
ABOUT MICHAEL KUEHLER
regulatory affairs- submission and approval of medical devices and device-drug / drug-device combination products- R&D medical devices project management
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