Freelance Norm Compliance Officer IGT Systems - already living in the Netherlands (ZZP)

Norm Compliance Officer IGT Systems - already living in the Netherlands

In 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 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

To 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 (e.g., 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 success

Related 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