Job Description

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  • Defining applicable standards and
    regulations for new products, such as IEC 60601 series, IEC 62304,
    IEC 62366-1, and EU MDR.
  • Outlining how these
    standards and regulations will be integrated into the Standards and
    Compliance plan to demonstrate
    compliance.
  • Creating project deliverables
    related to Norm Compliance.
  • Ensuring all
    specified legal requirements are implemented and verified by
    reviewing relevant project
    deliverables.
  • Assisting designers and testers
    with the interpretation and application of standards and
    regulations related to the technical design of IGT
    products.
  • Organizing and completing all
    documentation required to obtain product certification from
    independent certifying agencies.
  • Providing
    technical support to the Regulatory Affairs department in
    preparation for submissions to regulatory
    bodies.


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