Medical Device Assessor

il y a 1 semaine


Paris, Île-de-France SGS Temps plein
Job Title: Medical Device Assessor

At SGS, we are seeking a highly skilled Medical Device Assessor to join our team. As an expert in clinical diagnostic technologies, you will play a crucial role in ensuring that patients across Europe have access to safe and effective diagnostic tests.

Key Responsibilities:
  • Assess in-vitro diagnostic medical devices for strict compliance with the relevant European laws (EU IVDR)
  • Provide support for CE marking activities within SGS
  • Contribute to the training and qualification of junior staff
  • Develop comprehensive training materials
  • Expand and keep up-to-date your knowledge of relevant technologies, regulations, international standards, and best practice guidance documents
Requirements:
  • Minimum of 2 years of direct engagement in the design, manufacture, testing, or utilization of specific in-vitro diagnostic devices and technologies, or relevant scientific research
  • Degree or equivalent qualification in a relevant technical discipline such as medicine, engineering, biomedical science, microbiology, or biochemistry
  • Strong written English skills, as reports will be reviewed and queried in English
  • Direct experience with medical device development life cycle processes, regulatory submissions, and relevant standards such as ISO 13485 and ISO 14971
  • An in-depth knowledge of the European regulatory framework on medical devices is highly advantageous, but on-the-job training will be provided
What We Offer:
  • A flexible schedule and a fully remote work model
  • Endless opportunities to learn, grow your expertise, and fulfill your potential

We value diversity and are committed to creating a better, safer, and more interconnected world. If you are passionate about medical devices and regulatory compliance, we encourage you to apply for this exciting opportunity.


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