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