english €110.000 vacatures

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