Support Norm Compliance activities and deliverables for IGT- systems with all relevant mandatory international and national regulations including MDR and Philips Healthcare processes
Job Summary
Support Norm Compliance activities and deliverables for IGT- systems with all relevant mandatory international and national regulations including MDR and Philips Healthcare processes.
Securing the implementation and verification of all specified legal requirements by reviewing these related project deliverables.
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve.
Matching Summary
Support Norm Compliance activities and deliverables for IGT- systems with all relevant mandatory international and national regulations including MDR and Philips Healthcare processes.
Skills & Requirements
Must-have
Medical device regulations (MDR)
IEC 60601 series
IEC 62304
IEC 62366
Product safety standards knowledge
Regulatory compliance activities
Nice-to-have
Team player
Improvement activities and audits experience
Project management skills
Influence environment for project success
Key Requirements
11+ years of experience in the industry
3-5 years in Software and/or hardware Testing/Engineering
BSc/MSc degree in a technical field, health sciences or related