Product Assessor
hace 1 día
Job Summary:
We are seeking an experienced Product Assessor to join our team in the In Vitro Diagnostics (IVDR) department. As an IVDR Product Assessor, you will be responsible for assessing in-vitro diagnostic medical devices for compliance with the European Union's In Vitro Diagnostics Regulation (IVDR).
Key Responsibilities:
- Conduct technical file reviews against the EU In-vitro Diagnostics Regulation for Class A sterile, Class B and Class C devices.
- Verify compliance of technical documentation submitted by manufacturers against the regulatory requirements.
- Identify, document and seek to rectify instances where device technical files deviate from compliance with applicable requirements under the IVDR.
- Provide support for CE marking activities within SGS and contribute to the training and qualification of junior staff.
- Develop comprehensive training materials and communicate effectively with team members, clients, and other stakeholders.
Qualifications:
- At least 4 years of professional experience within the domain of healthcare products or in related activities.
- A 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.
- Proficient communication skills using modern electronic platforms and strong written English skills.
Why SGS?
Join a globally recognized and stable company, a leader in the Testing, Inspection, and Certification (TIC) industry. Enjoy a flexible schedule and a fully remote work model. Access SGS University and Campus for continuous learning options. Thrive in a multinational environment, collaborating with colleagues from multiple continents. Benefit from our comprehensive benefits platform.
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