Regulatory & Quality Assurance


QA/RA Professional

MSc, Engineering Management, DTU
Available for: Part-time, full-time, tasks

Contact us for full CV


  • RA/QA compliance and Project Management
  • Implementation of development and regulatory compliance projects throughout the value chain utilizing digital solutions and AI
  • Regulatory Master Data strategy and implementation
  • Architecture of and use of Req. Management systems
  • Implementation of labelling systems (QMS + Technical implementation)
  • Full MDR GAB analysis performed for Class I and II
  • Full Traceability System for Medical Devices (end to end)
  • Unique Device Identification strategy and implementation.
  • Complexity Management and mass customization for data digitalization and IoT usage
  • Automation and Robotics in various sectors

Key results

  • QA Responsible and PM for transfer of EC certificates in major life science company
    Validation of software support systems (RIM, Labelling, AMS)
  • Timely and successful release of major Class II and Class III Medical Devices
  • Prepared and performed successful MDSAP Audits (operations) Class IIa and IIb
  • FDA Design Transfer procedures developed and implemented in major Class II company. from zero to successful first FDA inspection
  • UDI procedures and system developed and implemented in Class I, II and III life science companies under both FDA and MDR
  • Full labelling readiness procedures and labels developed and implemented


Internationally recognized standards:

  • ISO13485; ISO15223; ISO20417:2021; IEC 62304
  • MDR 2017/745 and IVDR 2017/746 + MDD 93/42/EC, IVDD 98/79/EC [Medical Device & In Vitro Diagnostic Regulative]
  • ISO 14971 Application of risk management to MD
  • UDI [EU, FDA, worldwide]
  • FDA Regulation – Medical Devices
[CFR 21 part 11 and 8xx and beyond]
  • GS1 Standards [GTIN, GLN, GDSN, Digital Link, Digital Product Passport DPP]

Personal Characteristics

Life science and healthcare enthusiast with strong Project Manager experience in the areas of medical devices development, people management, organizational fit to regulatory requirements and regulatory program execution. Strong implementor of projects in larger complex organizations.

Driven by strategic development of the people, business, systems, and organizational processes. Worked with various regulatory project implementations under FDA 21 CFR, MDR/IVDR, MDSAP and ISO13485.


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