Support the 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 the Norm Compliance activities and deliverables for IGT- systems with all relevant mandatory international and national regulations including MDR and Philips Healthcare processes.
Defining, for products to be developed, the applicable standards and regulations such as e.g. IEC 60601 series, IEC 62304, IEC 62366, the new EU MDR.
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 the 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
support Norm Compliance activities
define applicable standards and regulations
create project deliverables
secure implementation and verification
support designers and testers
arrange and complete evidence for certification
provide technical support to Regulatory Affairs
Nice-to-have
team player
influence environment for project success
proven experience in improvement activities
proven experience in audits
Key Requirements
BSc/MSc degree in a technical field, health sciences or related
11+ years of experience in the industry
3-5 years in Software and/or hardware Testing/Engineering or similar roles
background in the global medical devices industry
Knowledge of product safety standards (e.g., IEC 60601)
familiarity with national and international regulations