Regulatory Compliance Specialist

2 weken geleden


Best, Noord-Brabant, Nederland Yacht Voltijd
About Yacht

Yacht is a leading provider of temporary staffing solutions for the healthcare and pharmaceutical industries. Our clients are global leaders in health technology and pharma, and we are committed to helping them find the best talent to drive their success.

Job Description

We are seeking a highly skilled Regulatory Compliance Specialist to join our team. In this role, you 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.

You will also be responsible for implementing and verifying all specified legal requirements, supporting testers with the interpretation and testing of standards and regulations concerning the technical design of image-guided therapy (IGT) products, and providing technical support to the Regulatory Affairs department with the preparation of submissions.

Requirements
  • Bachelor's or Master's Degree in Engineering, Biomedical Engineering, Regulatory Affairs, or a related field
  • > 3 years of experience in regulatory compliance or quality assurance
  • Knowledge and experience with Medical Device standards and regulations (such as IEC 60601-1 series, IEC 62304, IEC 62366, and EU MDR)
  • Demonstrated experience in developing and managing standards and compliance plans
  • Experience in supporting design and testing teams with interpreting and applying standards and regulations to technical designs
  • Experience providing technical support for regulatory submissions to bodies such as the FDA, EU regulatory authorities, and other relevant agencies
What We Offer

We offer challenging positions that allow you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development. This concerns a secondment contract with the possibility of extension and a permanent contract at the company. Full-time (40h) is strongly preferred, working 32 or 36 hours per week can be discussed. We will offer a competitive benefit package in line with your seniority and the seniority of the position (with max. 5400 euro per month based on 40 h per week).



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