Michael Kuehler

Regulatory Affairs Senior Expert Medical Devices @Bayer

Berlin, DE
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jun 2024 — Present

Regulatory Affairs Senior Expert Medical Devices @Bayer

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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

N/A

ESMT Berlin

Management excellence company program

1996 — 2000

Technische Universität Berlin

PhD, medical engineering

2005 — 2005

FernUniversität in Hagen

Certificate, Business administration compact seminar

1990 — 1996

Technische Universität Berlin

Graduate Engineer, Medical Engineering

SKILLS

Interventionelle KardiologieMedizinprodukteValidationStrategisches ManagementProduktentwicklungFdaProdukteinführungRStrategyBiomedical EngineeringMedical DevicesInterventional CardiologyStentsIso 13485BiomedizintechnikForschung Und EntwicklungRegulatory Affairs

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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Michael Kuehler — Regulatory Affairs Senior Expert Medical Devices at Bayer in Berlin, DE | Unifers