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Freelance Norm Compliance Officer IGT Systems

2 maanden geleden

Best, Noord-Brabant, Nederland Yacht Freelance Voltijd
Norm Compliance Officer IGT Systems - already living in the NetherlandsIn this role, you have the opportunity to:Be part of the Norm Compliance team, support the Norm Compliance activities and deliverables for IGT- systems with all relevant mandatory international and national regulations including MDR and Philips Healthcare processes.Participate in a cross functional development team, representing the Norm Compliance team, develop and execute the standards and compliance plan.You are responsible for:• Defining, for products to be developed, the applicable standards and regulations such as IEC 60601 series, IEC 62304, IEC , 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 countriesTo succeed in this role, you should have the following skills and experience:• A bachelors 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 ( , 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 successRelated to the standards in the medical domain, knowledge on the following standards is preferred:
  • IEC60601-1 series including collateral- and X-ray related particular standards.
  • IEC62304 and IEC62366-1
  • EU MDR and 21CFR820
  • Artificial intelligence related standards and regulations