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Freelance Norm Compliance Officer IGT Systems: A Technical Expertise Opportunity
2 maanden geleden
As a Freelance Norm Compliance Officer for IGT Systems, you will be part of a dynamic team responsible for ensuring the company's products comply with international and national regulations.
Key Responsibilities:- Regulatory Compliance: Define the applicable standards and regulations for products to be developed, including IEC 60601 series, IEC 62304, and EU MDR.
- Standards and Compliance Planning: Develop and execute the standards and compliance plan, ensuring all required standards and regulations are covered.
- Project Deliverables: Create project deliverables related to Norm Compliance responsibilities, including securing the implementation and verification of legal requirements.
- Technical Support: Provide technical support to designers and testers in interpreting and testing standards and regulations.
- Certification and Regulatory Affairs: Arrange and complete evidence for gaining product certification and provide technical support to the Regulatory Affairs department.
- Education: Bachelor's degree or higher in a technical field, health sciences, or related.
- Experience: At least 3-5 years in Software and/or hardware Testing/Engineering or experience in similar roles within a complex environment.
- Skills: Knowledge of product safety standards, familiarity with national and international regulations, and well-developed project management skills.
- Background in Medical Devices: Experience in the global medical devices industry.
- Knowledge of Artificial Intelligence Standards: Familiarity with artificial intelligence-related standards and regulations.
