CV

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.

Representative accomplishments:

  • 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

Professional experience:

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