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Compliance Expert for IGT Systems
2 maanden geleden
We are seeking a highly skilled Norm Compliance Officer to join our team at Yacht. As a key member of our Norm Compliance team, you will be responsible for ensuring that our IGT systems comply with all relevant international and national regulations, including MDR and Philips Healthcare processes.
Key Responsibilities
- Define the applicable standards and regulations for products to be developed, such as IEC 60601 series, IEC 62304, and EU MDR.
- Develop and execute the standards and compliance plan, representing the Norm Compliance team in a cross-functional development team.
- Create project deliverables related to Norm Compliance responsibilities, including securing the implementation and verification of all specified legal requirements.
- Support designers and testers with the interpretation and testing of standards and regulations, and arrange and complete all evidence for gaining product certification.
- Provide technical support to the Regulatory Affairs department for submission to Regulatory bodies and countries.
Requirements
- Knowledge of the following standards is preferred: IEC series, including collateral- and X-ray related particular standards, IEC 62304 and IEC 62366-1, EU MDR, and 21CFR820.
- Experience in regulatory affairs and compliance, with a focus on medical devices and IGT systems.
- Strong analytical and problem-solving skills, with the ability to interpret and apply complex regulations and standards.
- Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.
