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Regulatory Affairs Specialist for IGT
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, working closely with cross-functional development teams.
- Create project deliverables related to Norm Compliance responsibilities, including securing the implementation and verification of legal requirements.
- Support designers and testers in interpreting and testing standards and regulations, and arrange for product certification by independent certifying agencies.
- Provide technical support to the Regulatory Affairs department for submissions to regulatory bodies and countries.
Requirements
- Knowledge of medical domain standards, including IEC series, IEC 62304, IEC 62366-1, EU MDR, and 21CFR820.
- Experience with regulatory affairs and compliance in the medical device industry.
- Strong analytical and problem-solving skills, with attention to detail and ability to work in a fast-paced environment.
What We Offer
- A dynamic and collaborative work environment at Yacht.
- Opportunities for professional growth and development in a rapidly evolving industry.
- A competitive salary and benefits package.
