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
European Medico Consult ApS Weysesgade 44 DK-2100 Copenhagen Denmark
www.medico-consult.eu CVR: 40732241