Norm Compliance Officer IGT Systems
(We are searching for candidates who are already living in the Netherlands)
Start Date:ASAP
Duration of the contract: 1 year
Location:Eindhoven
...
-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
Related to the standards in the medical domain, knowledge on the following standards is preferred:
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