Medical Device Assessor
il y a 1 semaine
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
- 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
- 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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