Quality Assurance and Regulatory Affairs

ID1006

Senior Consultant RA/QA

MSc.
Available for: Part-time, full-time

Competences

  • Regulatory and QMS under MDR and IVDR.
  • Product conformity assessment, product classification, assessment route strategies.
  • MDD/MDR andIVDD/IVDR transition•Quality management: ISO 9001, ISO 13485, risk management.
  • Medical Device Engineering.
  • Software and Electronics engineering, embedded systems.

Key results

  • Implementation and maintenance of quality systems according to ISO 13485, covering management, R&D, production, sales, customer services, QA/QC.
  • Implementation of QMS add-ons for JGMP and KFDA.
  • Product registration in EU, Japan, Korea, Russia, China.
  • Author of International Continence Society Measure File Format (ICSMFF).
  • Medical device development and project management within urology, intensive care, and patient information systems.

Regulations/Standards

Extensive knowledge in:

  • MDR (EU) 2017/745, IVDR (EU) 2017/746, ISO13485.
  • EU Harmonized /Internationally Recognized Standards: IEC60601-1, ISO 14971, IEC62304, IEC62366, ISO 10993 series.
  • International Submissions and approvals in: EU, CFDA, KFDA, PMDA, DIN GOST.

Personal Characteristics

Is a pragmatic, constructive, and straight forward person that enjoys team working and an open minded dialogue.
He is innovative with a sense of problem solving.
Has experience in overviewing the entire structure of a company and is able co-ordinate its processes and their interfaces.

He spends his spare time restoring his vickory farm from 1697 under cultural heritage protection.

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