Clinical Compliance

ID1003

Senior Consultant Medical Device

MD, PhD, MPA from KU and CBS
Available for: Part-time, tasks

Competences

  • Project Management.
  • Clinical compliance (MDD).
  • Clinical compliance (MDR/IVDR).
  • Clinical trials and GCP.
  • Clinical Evaluations.
  • Expert insight within the healthcare sector.
  • Business innovation on the basis of science and research.
  • Fundraising.
  • R&D development and launch within Pharma, MedTech and Biotech.
  • ISO13485.
  • FDA 812 IDE.

Key results

  • Management of international projects and direct.
  • Liaison with auditors and authorities in relation to R&D development and audits.
  • International speaking for 30-750 people incl. keynotes.
  • Clinical Trial execution for private companies, research institutions and start-ups.
  • +35 peer-reviewed publications.
  • Development and launch of solutions and products within the healthcare space.
  • Attraction of +6 million euro in soft funding.
  • Clinical experience, 10 years +.
  • Creation and review of PERs, CERs and PMCF plans and reports for MD, IVD and SaMD.
  • Development of execution plansand strategic approach for PMCF/PMPF, CER/PER and risk evaluations.

Personal Characteristics

He is an innovative, thoughtful, constructive and straight forward person that believes in open dialogue and enjoys cross-functional collaboration. He has vast experience across the healthcare sector within the clinical area –ranging from medical affairs to clinical compliance with pharmaceutical, MD and IVD products. Spends his free time with DIY projects, family, friends, and various adventurous sports.

Contact

Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13

 contact@medicologic.com
 Medicologic-profile
Where to find us

Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com

Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com