Senior RA/QA SaMD Specialist

Cand.Scient. Health Informatics, KU
Available for: Part-time, full-time, tasks

Contact us for full CV


  • Medical devices regulatory compliance

  • MDSW/SaMD Life-cycle management
    Regulatory Strategy and Submission
    Digital Therapeutics (DTx)
    AI/ML Enabled Medical Devices

  • Project Management

  • Quality Assurance and Design Assurance

  • Design Control
    Risk Management
    Requirements Engineering / mngt.
    Usability Engineering
    Design Verification and Validation

  • Technical Writer
    Design Input/output deliverables
    Test Protocols and reports

Key results

He is specialised in medical devices regulatory compliance and market access. He cover several aspects/phases of Class I, Class IIa and Class IIb product development and maintenance with an enhanced focus on Medical Device Software (Stand-alone, embedded or as an accessory).

He has extensive knowledge of the regulatory landscape and market access requirements for medical devices in key markets such as: EU, US, Japan and Canada. This includes ensuring compliance with various industry standards, including but not limited to: ISO13485, ISO14971, IEC62304 and IEC82304.

Key results:
MDR Class I and MDR Class IIa from concept to product registration/submission (incl. Clinical Evaluation).

Standards & Regulation

  • MDR

  • FDA regulation

  • ISO 13485

  • ISO 14971 (+ISO/TR 24971:2020)

  • IEC 62304

  • IEC 82304

  • IEC 62366-1 and 62366-2

  • eDMS/eQMS Knowledge:
    GreenLight Guru,
    Veeva Vault,

  • Methods: Agile, SCRUM, SAFe5 and V-model

Personal Characteristics

He considers himself to be an open and highly collaborative team member. He truly values the importance of teamwork and believe that collective efforts bring the best results. He enjoys engaging in open and honest discussions on how to solve tasks or address and fix issues at hand, as he believes that diverse perspectives lead to better outcomes.

Furthermore, he is not just motivated by the assignment itself, but rather by the opportunity to find effective solutions and deliver outstanding results. He thrives on challenges and enjoy thinking outside the box to come up with innovative approaches.

In addition to his collaborative skills and problem-solving mindset, he is also excellent in managing his own time and tasks. He is highly organized and efficient, which allows him to prioritize effectively and meet deadlines with ease.


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