Senior Consultant Medical Device Compliance

MSc. Human Biology, Copenhagen University
Available for: Part-time, full-time, tasks

Contact us for full CV


  • Design Control.

  • Risk Management.

  • CAPA.

  • Design verification.

  • Design validation.

  • Human Factors / Usability.

  • Requirement Engineering.

  • Product maintenance.


  • Customer complaint investigation.

  • Inspection preparation and presentations.

  • Device accessories.

  • Process optimization and cLEAN.

  • Batch review and release of products as delegated QP.

Key results

Working with medical devices since my graduation has given me a holistic insight into the industry. I started my career in a medical device production as a delegated QP. I have extensive experience in product maintenance and R&D thus giving me valuable insights into the entire value chain.

I have a diverse profile with my biotechnological education combined with experience from both production, R&D and regulatory assignments. My background and career combined allows me to work with a wide range of subject areas from biologics over electronics to medical devices


  • SO13485:2016.

  • MDR (device regulation).

  • IVDR (In Vitro Diagnostics Regulation).

  • FDA regulation [CFR part 820].

  • ISO14971 (risk management).

  • IEC 62366 (Device Usability).

  • IEC 62304 (Device Software).

  • IEC 82304 (Health Software).

  • Microsoft Windows.

  • Microsoft Office 365.

  • Microsoft project.

  • Microsoft Visio.

  • Agile.

Personal Characteristics

I carry great concern for my co-workers and try my best to create a fun and positive environment. I thrive in a dynamic setting with short deadlines and difficult situations.

I enjoy being challenged by skilled colleagues as well as complex assignments in a busy environment. I am continuously trying to improve both at a personal and professional level.

As I have been working as quality representative most of my career, I am used to giving direction and setting boundaries according to the company guidelines. I am used to work in complex stakeholder situations in international companies with great diversity.

I am tech savy and a quick learner and can thus easily adapt to working with diverse and complex devices and software.


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