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The role of the Norm Compliance Officer for IGT Systems involves ensuring adherence to all relevant international and national regulations, including MDR and Philips Healthcare processes.
Key Responsibilities
- Identify applicable standards and regulations for product development, such as IEC 60601 series, IEC 62304, and EU MDR.
- Develop a comprehensive Standards and Compliance plan to demonstrate compliance through appropriate evidence.
- Create and manage project deliverables associated with Norm Compliance duties.
- Review project deliverables to ensure all specified legal requirements are implemented and verified.
- Assist design and testing teams in interpreting and applying standards and regulations to the technical design of IGT products.
- Coordinate and finalize all necessary documentation for product certification by independent certifying agencies.
- Provide technical support to the Regulatory Affairs department in preparation for submissions to regulatory bodies.
Preferred Knowledge
Familiarity with the following standards in the medical domain is advantageous:
- IEC series, including collateral and X-ray related particular standards.
- IEC62304 and IEC62366-1.
- EU MDR and 21CFR820.
- Standards and regulations related to artificial intelligence.
This position is an opportunity to contribute to innovative health technologies and solutions that enhance lives globally.
