Highlights of qualifications:
- 14 years of leadership experience with Regulatory Affairs for Medical Devices, incl. Regulatory Strategies, Quality Management, Design Control, Post Market Regulatory Reporting of Adverse Events and Recalls, collaboration with Notified Bodies and the FDA.
- Experience from several Start-Up companies as well as larger companies and Matrix Management.
- Expertise in Medical Device product development and market approvals.
- Expertise in Medical Devices from various industries, such as cardiovascular implants, pre-filled syringes, active devices, medical software and drug/device combination products.
Theoretical background within Economy/International Business, and Natural Science.
- US: IDE, PMA and 510(k) submissions
- CE marking of class I-III Medical Devices
- Market approvals globally
- FDA Inspections and communication
- Notified Body audits and communication
- General Management
Education and credentials:
2013 Project Management, Cook Medical
2012 Leadership, Cook Medical
2010 HD, International Business, Copenhagen Business School
2007 Leadership Development Programme, AkzoNobel
2001 M.Sc. Biology, University of Copenhagen, Denmark
2016 – 2018 IWA Consulting ApS: Head Medical Device RA & QA
2014 – 2016 Widex A/S: Director, Global Regulatory Affairs
2011 – 2014 William Cook Europe: Manager, Regulatory Affairs
2008 – 2011 Contura International: Director, Regulatory Affairs
2007 – 2008 Contura International: Specialist, Regulatory Affairs
2002 – 2007 Akzo Nobel A/S: Team lead, Microbiology Laboratory