ID1062
Senior Clinical Compliance Consultant
MD, University of Copenhagen
Available for: Part-time, full-time, tasks
Contact us for full CV
Competences
- Project management
- Clinical evaluations
- Clinical compliance (MDR/IVDR)
- Clinical trials and GCP
- Clinical investigations and GCP
- Expert insight within the healthcare sector
- Business innovation on the basis of science and research
- Fundraising
- R&D development and launch within MedTech
- Literature and vigilance
- ISO 14155, 13485 and 14791
- Startup and early-stage project scoping
Key results
- Clinical Trials and clinical investigation execution for private companies and start-ups
- Peer-reviewed publications
- Development of solutions and products within the healthcare space
- Attraction of +4 million SEK in angel funding
- Clinical experience, +5 years
- Creation and review of clinical documentation packages including CIPs, CIRs, CEPs. CERs and PMCF plans and reports for medical devices
- Development of execution plans and strategic approach for medical device projects
- Clinical and technical reviews to Notified Bodies as part of transition from MDD to MDR
Software/Standards
- Clinical evaluation according to MDR regulations and MEDDEV 2.7.1 rev. 4: author and evaluator of Clinical Evaluation Plans and Reports
- ISO 14155
- ISO 13485
- ISO 14791
- GCP
- GDP
- IMFDR
Personal Characteristics
He has vast experience across the healthcare sector within the clinical development area – ranging from medical devices to pharmaceutical trials.
He has a personal trait that makes people feel safe and empowered through his calm nature and optimistic view on things. He truly believes there is always a way to move forward.
His values are excellence, integrity and innovation.
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