Senior Consultant and Principal Advisor
Available for: Tasks
Contact us for full CV
- Change Management.
- Quality Management and Implementation.
- IT-system for QA.
- Process optimizing.
- Process validation.
- GMP (Good Manufacturing Process).
- Project Management.
- Program Management.
- Audits/ Inspections (FDA / MDSAP) TGA, CFDA and others.
- Management Review.
Management of corporate QA function in both a large Danish and US Medical Device/IVD company Securing compliance and well performed Audits – no major observations.
Aligning QA strategies with Business goals – Training and implementation of SOP’s in global scale MDSAP certification, Legal entity transfer, Preparing for IVDR and MDR.
Extensive knowledge in:
- ISO13485 og 14971
[Medical Device QS and Risk Management]
- FDA regulation
[CFR part 820, CFR part 11, UDI]
[ICH Q7, Q9 and Q10, GAMP 5, GHTF Process validation]
He is a pragmatic and straight forward person that believes in an open and honest dialogue, he enjoys working with others.
Has many years hands-on experience in implementation and integration of management systems and LEAN.
Spends his free time with family, boating, skiing, diving, kiting and running.
Arne Jacobsens Alle 15-17
DK-2300 København S
(+45) 48 24 51 13
Where to find us