Job Title Norm Compliance Officer
You are responsible for
- 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
- 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
You are a part of
The Norm Compliance team and support the Norm Compliance activities and deliverables for IGT- systems with all relevant mandatory international and national regulations including MDR and Philips Healthcare processes. The team is currently 12 people strong, operates as one scrum team and now also works on sustainability topics.
To succeed in this role, you ll need a customer-first attitude and the following
- BSc/MSc degree 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