Regulatory Affairs


Senior RA Consultant

PhD, MSc Human Biology
Available for: Part time


  • Regulatory Affairs Strategies for Medical Devices.
  • Medical Device Classification including Borderline Products.
  • FDA Submissions:Presubmissions, Pre-Request for Designation, 510(k), De Novo Requests, 30 Days Notices, PMA Annual Reports, etc.
  • Technical File compilation for EU MDR certification.
  • Clinical Evaluation Plansand Clinical Evaluation Reports.
  • Change Control including process optimization and authority submissions.
  • Support during investor due diligence processes in start-ups (questions related to regulatory/compliance topics).
  • Project Management.
  • Hands-on technical/scientific/medical writing.

Key results

  • Successful submissions to competent authorities related to product approvals and device change notifications.
  • Applying FDA’s Q-Submission program to achieve early feedback on planned development activities to facilitate a targeted and efficient product development process.
  • Active participant in the successful sale of a company:
    Responsible for presenting and addressing all questions concerning regulatory compliance and product safety & performance during due diligence process.
  • Key participant in raising 12 mio- DKK from Innovation Fund Denmark for a 4-year interdisciplinary innovation project.
  • Building high performing teams through mutual respect and trust with a clear direction and purpose.


  • Medical Device Regulation (EU) 2017/745(MDR) and related MDCG / MEDDEV Guidances.
  • Medical Device Directive 93/42/EEC (MDD).
  • FDA Regulation [21 CFR part 820etc] and relatedFDA guidance documents.
  • Harmonised Standards and Recognised Consensus Standards: ISO10993 series, ISO14971; ISO13485.

Personal Characteristics

She is enthusiastic about bringing safe new medical device products to the market.
She applies her broad scientific and regulatory background to support teams and projects to achieve timelines and objectives.

She thrives at the interface between science and business and understands the importance of a close and well-coordinated collaboration across corperate functions.

She spends her free time with family, friends, volunteer work, nature, and running/walking.


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