Dr. Stefan Menzl

Angestellt, Vice President EMEA Regulatory & Quality, Artivion EMEA
Remchingen, Germany

Fähigkeiten und Kenntnisse

Regulatory affairs
clinical trial management
Quality assurance
vigilance
compliance
EU-MDR-Readiness
quality systems
medical devices
pharmaceuticals
general management
negotiation
cardiovascular
ophthalmology
implants
drug-device combinations
medical devices containing material of animal orig
Change Management
cultural management
FDA / Global Readiness
Global Harmonized Qualitymanagement-System
Interim Management
Wound Care
MDSAP
Due Diligence
ISO 13485:2016
Submission Strategy
Management
Consulting

Werdegang

Berufserfahrung von Stefan Menzl

  • Current 1 year and 5 months, since Jan 2025

    Vice President EMEA Regulatory & Quality

    Artivion EMEA

    Regulatory and Quality

  • Current 8 years, since Jun 2018

    Geschäftsführer / Executive Director

    Qserve Group Deutschland GmbH

    Qserve, the leading European medical device and IVD consultancy group, has opened a German office. This development significantly enhances Qserve’s ability to service the medical device and IVD market in Germany, Austria and Switzerland, as well as servicing its global customers. Besides MDR/IVDR support, Qserve Germany offers support for market access to the US and China. Projects will be managed from the German office, using our local experts in the Qserve offices in those countries.

  • Current 8 years and 8 months, since Oct 2017

    Principal Consultant

    Qserve Group

    Strategische und praktische Unterstuetzung in den Bereichen Regulatory Affairs, Quality-Management und klinische Bewertung von Medizinprodukten & IVDs.

  • 2 years, Oct 2015 - Sep 2017

    Global Vice President Quality & Regulatory Affairs

    Paul Hartmann AG

    Strategic Leadership of global Quality- and Regulatory Organization across the Paul Hartmann Group.

  • 4 years and 8 months, Jan 2011 - Aug 2015

    Director International Regulatory Affairs

    Abbott Medical Optics

  • 1 year and 11 months, Feb 2009 - Dec 2010

    Director Regulatory Affairs & Compliance EAM

    Abbott Medical Optics

  • 3 years and 7 months, Jul 2005 - Jan 2009

    Director Regulatory Affairs, Compliance & Clinical EAM

    AMO Germany GmbH / Abbott Medical Optics

  • 5 years and 3 months, Apr 2000 - Jun 2005

    Director Regulatory & Quality Affairs

    Edwards Lifesciences

  • 4 years and 5 months, Nov 1995 - Mar 2000

    Regulatory Affairs Manager

    Baxter

  • 1 year and 2 months, Jun 1991 - Jul 1992

    Scientist / R&D

    Biosystem GmbH

Ausbildung von Stefan Menzl

  • Julius Maximilians Universität Wuerzburg

Sprachen

  • German

  • English

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