Norm Compliance Officer

Posted Apr 18, 2019
Project ID: PHILJP00019798
Best , Brabant
4 months (May 6, 2019 - Aug 31, 2019)
40 hrs/week
Payrate range
0 - 66 €/hr
Norm Compliance Officer (grade 60) IGT Systems

For Fieldglass:

In this role, you have the opportunity to:
Provide Norm Compliance support and oversight in iGT systems. Within the Project ensure compliance with all applicable standards (IEC and others) for these products
Participate in a cross functional (medical) development team, representing the Norm Compliance team and develop and execute the standards and compliance plan.

You are responsible for:
•   Defining, for products to be developed, the applicable safety standards and regulations such as IEC 60601 series and/or IEC 62304, IEC 62366, the new EU MDR
•   Defining within the Standards and Compliance plan how the required standards and regulations will be covered into evidence for demonstrating compliance
•   The 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

To succeed in this role, you should have the following skills and experience:
•   A Bachelor’s 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 (e.g. IEC 60601) would be preferred
•   Familiarity with other national and international regulations such as – RoHS and REACH is an advantage.
•   Well-developed project management skills would be preferred
•   Team player that can influence environment for project success
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