Helene Quie
Owner and Managing Director
Relevant Job Experience
Helene founded Qmed Consulting in 2006. Prior to that, Helene worked for more than 11 year in the medical device and pharmaceutical industry in clinical research management, regulatory affairs and product management.
Her clinical experience covers several medical areas, including neurology, cardiology and radiology. She has worked with medical devices in all risk classes, including drug-device combination products.
She has vast experience in the product development; design, conduct and management of clinical investigations; and regulatory strategy and submissions. During her professional career she has worked at companies of different sizes, e.g. COOK Medical, Lundbeck, Ambu and Millimed.
She has an in-depth understanding of the challenges encountered by the life science industries in their effort to develop, document and market their products.
Helene has arranged and lectured at courses and she has supplemented her work experience with several courses of in medical, clinical and regulatory field.
Education
1995 M Sc in biology from the University of Odense, Denmark with specialty in cell biology.