Quality Assurance and Regulatory Affairs
Principal Advisor QM/RA
Available for: Part-time
Contact us for full CV
- Management/Project Management.
- In-depth knowledge of Quality Management Systems World Wide (ISO 9001 / 13485, CMDCAS, MDSAP, Taiwan, TGA & 21CFR820).
- Design Control and DHF
- In-depth knowledge of establishing, maintaining and certification of Quality Management Systems.
- More than 25 years of international audit experience within Quality Management Systems according to MDD 93/42/EEC, IVDD 98/79/EEC& MDR
- Quality Management, Risk Management, Usability, Validation, Clinical Evaluation, Biocompatibility Evaluations, Shelf life/Stability study, Electrical Safety, EMC, Vigilance, FSCA, CAPA, Process Validation, Sterilization & Clean Room.
- QP (Qualified Person).
- Management Representative/ CTO& Certified Lead Auditor – ISO13485 & CE marking according to MDD 93/42/EEC.
- QA/RA Manager in an international company manufacturing heart / lung machines and disposables for open heart surgery.
- QA Department manager / project manager in an international company manufacturing electrical- and mechanical equipment for the defence industry.
- QA/Logistic Manager in a company manufacturing mechanical equipment.
- Medical Device Manager for an international accredited certification body.
- As Former CTO & part owner of a Dental Laser equipment company, obtained ISO 13485certification, CE and CFDA approval.
- As independent consultant prepared a number of medical device companies for ISO 13485 & CE certification.
- Conducted +1500 international ISO 13485/ CE audit for several NB & Accredited bodies.
Extensive knowledge in:
- Medical Device Directive MDD 93/42/EEC, In Vitro Diagnostic Directive 98/79/EC& MDR.
- ISO 13485 / 9001CMDCAS, Taiwan, TGA etc.
- EU Harmonized/Internationally recognized standardsi.e.ISO13485, ISO14971, EN62366, MEDDEV2.7/1, ISO10993 EN60601-X-XX, EN62304, MEDDEV2.12/1.etc.
- Project Management. International System & CE auditing including TechnicalFile review.
Has a pragmatic and constructive approach and believes that results are best achieved in a straightforward open minded dialogue between the parties.
He spends his spare timewith the family in the summer house and on sports (golf, mountain biking and skiing).
He is also interested in literature and music.
Arne Jacobsens Alle 15-17
DK-2300 København S
(+45) 48 24 51 13
Where to find us