Quality Assurance and Regulatory Affairs
Senior Consultant RA/QA
Available for: Part-time, full-time
- 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.
- 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.
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.
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.