About me

Ellen Jespersen

– my Professional Profile

  • I am a very experienced global oriented QA and RA Manager with 25 years’ experience and success in forging Quality Management Systems for both large and small manufacturers of medical devices
  • I have been Manager of the Danish Competent Authority for Medical Devices, an experience which has given me a solid foundation for understanding and interpreting the regulatory requirements on Medical Device manufacturers
  • I thrive on developing, implementing and running lean and compliant quality processes that live up to current regulations
  • I have extensive experience managing the preparation of external audits and in hosting audits and inspections from Notified Bodies, FDA, Brazilian Authorities, Korean Authorities etc.
  • I am conscientious, hands-on and performance driven and take pride in delivering results and offering support in line with business needs

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European Medico Consult ApS      Weysesgade 44      DK-2100 Copenhagen      Denmark

www.medico-consult.eu      CVR: 40732241