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The role of the Norm Compliance Officer for IGT Systems involves ensuring adherence to essential international and national regulations, including the Medical Device Regulation (MDR) and Philips Healthcare protocols.
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 regulatory adherence.
- Create and manage project deliverables associated with Norm Compliance duties.
- Review project outputs to ensure all legal requirements are met and verified.
- Assist design and testing teams in understanding and applying relevant standards to IGT product designs.
- Compile and finalize documentation necessary for product certification by independent agencies.
- Provide technical support to the Regulatory Affairs department for submissions to regulatory bodies.
Preferred Knowledge
Familiarity with standards in the medical field, including:
- IEC series and related collateral standards.
- IEC 62304 and IEC 62366-1.
- EU MDR and 21 CFR 820.
- Standards and regulations pertaining to artificial intelligence.
In this role, you will contribute to impactful projects and innovative health technologies that enhance the quality of life globally.
