norm compliance officer igt systems.

- 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.

Preferred 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.