Eindhoven, North Brabant, Netherlands
Experienced Product Development Expert: - Management of multidisciplinary development projects - Development process improvement - Compliance expert in medical device business, both Regulatory and Quality
Responsible for projects, operations, QA and RA
Hands-on regulatory affairs support for small and large active medical device manufacturers - Regulatory strategy and submission management (CE, FDA, ...) - Risk management moderation (ISO14971) - Medical device software (IEC62304, TIR45) - Smart documentation strategies (lean DHF, DMR) - Lean QMS implementation (ISO13485, QSR) and audits
Providing consultancy and training on medical device regulations. ISO13485, FDA 21CFR820, USA product approvals, Medical device SW development, medical device risk management.
Tracking international regulations for medical devices, managing worldwide regulatory approvals, regulatory consultancy, ISO9001 and 13485 audits, development process consultancy.