Regulatory Compliance Officer
3 weken geleden
About Yacht
Yacht is a dynamic and international company offering challenging positions that allow professionals to grow and develop in a fast-paced environment. We are seeking a Regulatory Compliance Specialist to join our team.
Job Description
The Regulatory Compliance Specialist will be responsible for providing support in the development of Standards and Compliance plans, creating project deliverables related to Norm Compliance responsibilities, and defining standards and regulations for products under development. This includes IEC 62304, IEC series, IEC 62366, and EU MDR.
Responsibilities
- Develop and manage Standards and Compliance plans
- Create project deliverables related to Norm Compliance responsibilities
- Define standards and regulations for products under development
- Implement and verify legal requirements
- Support testers with the interpretation and testing of standards and regulations
- Provide technical support to the Regulatory Affairs department
Requirements
- Bachelor's or Master's Degree in Engineering, Biomedical Engineering, Regulatory Affairs, or a related field
- More than 3 years of experience in regulatory compliance or Quality Assurance
- Knowledge and experience with Medical Device standards and regulations
- Experience in developing and managing standards and compliance plans
- Experience in supporting design and testing teams
- Experience providing technical support for regulatory submissions
Terms of Employment
Yacht offers a competitive benefit package in line with seniority and position. The position is a secondment contract with the possibility of extension and a permanent contract at the company.
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