Regulatory Affairs & Project Management


Regulatory Affairs & Project Management

MSc Nanoscience, Aarhus University
Available for: Part-time, full-time, tasks

Contact us for full CV


  • Project Management, R&D

  • Design Controls, R&D

  • FDA approval process (PMA, De-Novo)

  • Technical/regulatory writing incl. gap analysis

  • Implants

  • Biocompatibility

  • Sterile barrier systems incl. sterilization

  • Stability (shelf life) / Transportation

  • Audit SME (Design control)

  • Regulatory inquiries

  • Manufacturing problem solving and optimization

Key results

Continuous delivery of projects in accordance with agreed quality, budget and timeline.

Numerous successful regulatory approvals achieved (Class 1s-III), incl. PMA approval in US (class III).

Numerous audits from FDA, Europe and rest of world completed with no observations.

Continuous ability to address and close technical inquiries from competent authorities.



  • MDD, MDR, CFR 21 part 820


  • ISO 13485 (Quality Standard)

  • ISO 14708-1 / EN 45502-1 (Active implantable medical devices)

  • ISO 14971 (Risk Management)

  • ISO 10993 (Biocompatibility)

  • IEC 62366-1 (Usability)

  • IEC 60601 (Electrical safety)

  • ISO 11135 (ETO Sterilization)

  • ISO 11607-1 (Sterile Barrier System)

  • ASTM D4169 (Transportation)

Personal Characteristics

He is known for his goal-oriented way of working, effortlessly mixing a forward-looking attitude with a special blend of humor and dedication.

His great skill in connecting with team members through strong social abilities creates a team-oriented and pleasant atmosphere at work.

This balance between being professional and light-hearted, together with his focus on good results, clearly marks him as a highly valued and respected team member.

Moreover, his approach to work shows the Danish values of practical thinking, teamwork, and a friendly, personal way of interacting, making him an essential part of any collaborative project.


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