Principal Advisor and Team Lead

Cand.brom., EBA
Available for: Part-time, full-time, tasks

Contact us for full CV


  • EU: Medical device regulation (MDR) and PRRC.

  • US: FDA 510(k) submission.

  • Regulatory strategy and registration.

  • QMS management- ISO13485, ISO 9001, 21 CFR 820.

  • GMP, MDSAP and USDA regulation.

  • Post Market surveillance (PMS).

  • Technical File for CE marking.

  • Quality management/representative.

  • Supplier Quality Management.

  • Gap Analyses and create plans.

  • Project and People management.

  • Change management.

  • Communication – hands on and training.

  • Process optimization – LEAN/SCRUM.

Key results

  • Prepared and obtained 510K a clearance on a medical device system.

  • Obtained MDR certificate and act as Personal Responsible for Regulatory Compliance (PRRC) without any major findings.

  • Changed collecting of design control documentation for compiling technical files.

  • Optimized and Implemented PMS program integrate as product review within management review (QMR) and in compliance with MDR.

  • Built and provided leadership of several QA and RA teams fit to business and compliance need successfully.

  • Rebuilt QMS from startup company to future needs with a scalable QMS solution across a global world leading company.

  • Convert supplier quality management into clear overview and operational process.

  • Mentored for other younger QA managers and QA/RA specialists.


  • Medical Device Regulation (MDR) 2017/745.
  • Medical Device Directive (MDD) 93/42/EEC.
  • MDSAP.
  • USDA (US Department of Agriculture).
  • EU Harmonized/International standards ISO13485:2016, ISO 9001, ISO14971 and EN60601, etc.
  • FDA regulation 21 CFR-part 820.
  • ICH guidelines such as ICH Q7 and Q9.
  • Microsoft Office 365.
  • Quality systems as: Agile, Highstage, Trackwise, NovoGlow, Veeva Vault.

Personal Characteristics

She is an experienced and solution-oriented QA/RA with more than 25 years of experience in healthcare industry.

She brings extensive quality management system – and regulatory knowledge within life science and possess a deep understanding of the importance of collaboration between business and compliance to achieve results.

She meets the organization at current state, and she can support broadly in an organization with her solid QA/RA knowledge, where needed.
Customized solutions are driving through process-oriented and pragmatic approach with a strong drive and with a sense of humor.

She is focused on the goal and how to anchor the deliverables back to the business.


Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
(+45) 48 24 51 13
Where to find us

Michael Funder
Owner / Director
(+45) 20 64 41 46

Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05