Norm Compliance Officer - Koninklijke Philips N.V.
Norm Compliance Officer - Koninklijke Philips N.V.
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Summary
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Norm Compliance Officer binnen Philips gericht op de Medical Devices
- Defining, for products to be developed, the applicable standards and regulations such as e.g. IEC 60601 series, IEC 62304, IEC 62366-1, 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
- Dependable on work 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
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