Freelance Norm Compliance Officer IGT Systems (ZZP)

Please note:

• Please list all the required knowledge and answer YES and an explanation, in addition to the CV

• We would like to receive a CV that clearly shows that you meet the strict requirements.

• Although we work with deadlines, it is possible that the project will still be closed earlier. We advise you to respond as soon as possible.

Regulatory Compliance Officer

•  IGT Systems(We are looking for candidates who are currently based in the Netherlands)

• Start Date: ASAP

• Duration of the contract:

• 1 year

• Location:Eindhoven

Support the Norm Compliance team's efforts and deliverables for IGT-systems that adhere to all applicable national and international laws, including Philips Healthcare procedures and MDR.Develop and implement the standards and compliance plan while serving as a representative of the Norm Compliance team in a cross-functional development team.Working at Philips will allow you to contribute to advanced health technology and solutions that enhance the lives of billions of people worldwide and work on initiatives that will change lives.

- Identifying relevant standards and laws (e.g., EU MDR, IEC 60601, IEC 62304, IEC 62366-1) to design products.- Defining the plan to incorporate rules and guidelines for demonstrating compliance- Creating deliverables for norm compliance and ensuring the implementation and verification of legal requirements.-Assisting testers and designers in interpreting and evaluating rules and guidelines pertaining to the technical design of IGT products-Assembling and finishing the documentation required for the independent certifying body to certify the product-Providing technical support to the Regulatory Affairs division for preparing submissions to regulatory bodies and authorities.

Knowledge in the following medical domain standards:

• IEC 60601-1 series, including collateral and X-ray-related standards.

• IEC 62304 and IEC 62366-1.

• EU MDR and 21 CFR 820.

• AI related standards and regulations.