Helene Quie

Medical Device regulatorisk og kliniske specialistKøge, DanmarkI have a degree in Science specialised within cellbiology from the University of Odense. I have 25 years of experience within the pharma and medical device industries working for inter alia Cook Medical A/S, H. Lundbeck A/S, AMBU A/S and Millimed A/S. My primary expertise is within the clinical and regulatory areas such as device development, quality management, project management, clinical trial execution, market access and general management.

Bestyrelseserfaring

2018 -

Bestyrelsesmedlem @ NEURESCUE ApS

Erhvervserfaring

2017 -

Clinical and Regulatory Manager @ SONOCLEAR AS

2005 -

CEO @ QMED CONSULTING A/S

2003 - 2006

Clinical and regulatory affairs manager @ MILLIMED A/S

2001 - 2004

Clinical affairs manager @ AMBU A/S

2000 - 2002

Product Manager @ NUNC A/S

1999 - 2001

Clinical Coordinator @ H. LUNDBECK A/S

1994 - 2000

Clinical Project Manager @ WILLIAM COOK EUROPE ApS

Uddannelser & kurser

1987 - 1994

M.Sc. Cell biology @ Odense Universitet

Handlinger

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Ekspertiseområder

klinisk afprøvning med medical devices

Regulatoriske forhold for medical devices

Quality assurance

Design Control medical devices

Strategi og planlægning medical devices

REimbursement og market access medical devices

Start up medtech business "struggles"

Sprog

Dansk

Engelsk

Svensk

Norsk

Tysk

Fransk