In this role, you have the opportunity to:

Be part of the Norm Compliance team, support the Norm Compliance activities and deliverables for IGT- systems with all relevant mandatory international and national regulations including MDR and Philips Healthcare processes

Participate in a cross functional development team, representing the Norm Compliance team, develop and execute the standards and compliance plan.

You are responsible for:
? Defining, for products to be developed, the applicable standards and regulations such as e.g., IEC 60601-1 series, IEC 62304, IEC 62366 and EU MDR
? Defining within the Standards and Compliance plan how the required standards and regulations will be covered into evidence for demonstrating compliance.
? Creating project deliverables related to Norm Compliance responsibilities.
? Securing the implementation and verification of all specified legal requirements by reviewing these related project deliverables
? Supporting designers and testers with the interpretation and testing of standards and regulations with respect to the technical design of IGT products
? Arranging and completing all evidence for gaining product certification by the independent certifying agency
? Providing the Regulatory Affairs department with technical support as preparation of submission to Regulatory bodies and countries


To succeed in this role, you should have the following skills and experience:
? A bachelor’s degree or higher in a technical field, health sciences, or related
? At least 3-5 years in Software and/or hardware Testing/Engineering or experience in similar roles within a complex environment
? A background in the global medical devices industry would be considered a strong plus.
? Knowledge of product safety standards (e.g., IEC 60601) would be preferred.
? Familiarity with other national and international regulations is an advantage.
? Well-developed project management skills would be preferred.
? Proven experience in improvement activities and audits is an advantage.
? Team player that can influence environment for project success.