Senior Regulatory Specialist @ (July 2021 - November 2021)
Regulatory Principal Advisor @ (April 2021 - June 2021)
Director of Regulatory Affairs @ (September 2020 - March 2021)
Regulatory Affairs Specialist @ (November 2018 - September 2020)
Regulatory Affairs Manager @ (February 2016 - October 2018)
Regulatory Affairs Specialist @ (February 2011 - January 2016)
Development Scientist @ (February 2008 - January 2011)
Mette Ambirk Education
Danmarks Tekniske Universitet
Bachelor of Chemical Engineering (Polymer Chemistry)
2004-2008
Jordemoderskolen I Aalborg
Midwife
1996-2000
Mette Ambirk Skills
FDA
Medical Devices
ISO 13485
R&D
Lean Manufacturing
Design Control
CAPA
ISO 14971
GMP
Quality System
Regulatory Affairs
Validation
Regulatory Submissions
Change Control
V&V
Leadership
Sales
Pharmaceutical Industry
Research
Mette Ambirk Summary
Mette Ambirk, based in Denmark, is currently a Regulator Affairs Manager at DGS Diagnostics A/S. Mette Ambirk brings experience from previous roles at DGS Diagnostics A/S, Qmed Consulting A/S and RSP Systems A/S. Mette Ambirk holds a 2004 - 2008 Bachelor of Chemical Engineering in Polymer Chemistry @ Danmarks Tekniske Universitet. With a robust skill set that includes FDA, Medical Devices, ISO 13485, R&D, Lean Manufacturing and more. Mette Ambirk has 1 emails on RocketReach.
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