RA/QA Expert

MSc Chemical Engineering, DTU
MBA, Bocconi University, Italy
Available for: Part-time, full-time, tasks

Contact us for full CV


  • Quality management & Management representative

  • PRRC (MDR) & EU authorized rep.

  • Executive management, strategy

  • Gap Analysis

  • Set up of KPI’s for QMS processes and business.

  • Distributor Management (ref. MDR article 14)

  • Quality systems implementation (ISO13485/ QSR part 820)

  • Design Control

  • Design Dossiers and Technical File for CE marking.

  • FDA 510(k) submission

  • Communication with authorities

  • Preparation and submission of international registrations for medical devices and for IVDs.

  • Trained Lead auditor; supplier audits, internal audits

  • Risk Management, CAPAs

  • Software Validation, Process- and sterilization validation

  • Change Control

Key results

15+ years in the medical device industry. Worked in big corporations as well as extensive experience with MedTech startups.

Various Director roles within QA and RA functions in several international companies.

Built and certified ISO 13485 quality management systems.

International registration of various devices.

Creation of regulatory and quality strategies for MedTech startup companies.

Achieved CE mark of an active implantable medical device.

Global Director of multi-site QA operation. Oversight of 150+ FTEs.

Standards & Regulation

  • ISO 13485 – Medical devices – Quality Management

  • ISO 14971 – Medical devices – Risk management

  • ISO 10993 – Biological evaluation of medical devices

  • ISO 14155: Clinical Investigation – GCP

  • IEC 62366-1 Usability

  • EU Directives: Medical Device Directive MDD 93/42/EC, in vitro diagnostic directive IVDD 98/79/EC, AIMDD 90/385

  • EU regulations: Medical device regulation 2017/745, In vitro diagnostic medical devices 2017/746

  • FDA regulations: CFR 21 Part 820, Part 11, 803, 806

  • ISO 14155: Clinical Investigation – GCP

  • ISO 15223-1 Labelling of medical devices

  • ISO 11135 – Sterilization of health-care products ETO

  • ISO 11137-1 Sterilization using Gamma Radiation

  • ISO 11607-1; -2 Packaging

Personal Characteristics

He has a broad experience within MedTech Quality Management and Regulatory Affairs. By education an engineer and an MBA, which in combination gives both a holistic approach and the ability to dive deep into technical aspects. He has hands-on experience with every aspect of quality management and Regulatory Affairs from the startup world and extensive management experience from large international corporations.

In his free time He is a passionate father of 3 and therefore spends more time watching sports than exercising – although he does some yoga, mountain biking and running when time permits. He is an avid skier and loves to travel to Spain to practise his Spanish language and enjoy Mediterranean food.


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