ID1066
Senior RA Expert MD and IVD
M.Sc, PhD, RAC, Copenhagen University
Available for: Part-time, full-time, tasks
Contact us for full CV
Competences
- Regulatory Affairs Certified (RAC) by RAPS in EU, US, ROW
- Certified PR 365: MD-QMS ISO 13485:2016 Lead Auditor CQI-IRCA
- Medical Devices and In Vitro Diagnostics products registrations: EU, US, China, Australia, Canada and ROW
(mostly for high-risk products) - Collaborations on all stages with NB, FDA, EMA
- Project management
- Vigilance
- Change Control
- Clinical documentation (example CER) and Clinical studies (with CROs)
- MDSAP
Key results
- 10+ years in the medical device industry. Worked in big corporations as well as extensive experience with MedTech
startups. - Leading project MDR for approximately 60+ products Class III.
- Leading high-class registrations in China including type testing.
- Successful submissions to FDA (several 510(k), DeNovo submission including eSTAR program) for both adults and pediatric patients’ population.
- Always successful audit participant in the RA responsibility area.
Software/Standards
- ISO 13485 – Medical devices – Quality Management
- ISO 14971 – Medical devices – Risk management
- ISO 10993 – Biological evaluation of medical devices
- ISO 14155: Clinical Investigation – GCP
- IEC 62366-1 Usability
- EU Directives: Medical Device Directive MDD 93/42/EC, in vitro diagnostic directive IVDD 98/79/EC, AIMDD 90/385
- EU regulations: Medical device regulation 2017/745, In vitro diagnostic medical devices 2017/746
- FDA regulations: CFR 21 Part 820, Part 11, 803, 806
- ISO 14155: Clinical Investigation – GCP
- ISO 15223-1 Labelling of medical devices
- ISO 11135 – Sterilization of health-care products ETO
- ISO 11137-1 Sterilization using Gamma Radiation
- ISO 11607-1; -2 Packaging
Personal Characteristics
Is an energetic, highly driven, and passionate regulatory affairs expert with a keen interest in regulatory news and knowledge. Holds a degree in International Diplomacy (2010) and a PhD from Copenhagen University, showcasing a strong
technical background. The dedication to science has been recognized multiple times, including receiving the Student Nobel Prize honor from the President of the Republic of Poland and a nomination for the Young Investigator Award by Merck & Co.
This unique combination of skills and achievements makes an exceptional negotiator for companies in their communications with authorities.
In the free time, enjoys spending time with the children, relaxing by the water, gardening, and organizing the home.
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