IVDR Product Assessor

hace 3 días


Madrid, Madrid, España Sgs Société Générale De Surveillance A tiempo completo

At SGS, we are seeking an experienced IVDR Product Assessor to join our team of regulatory professionals. 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.

The European In Vitro Diagnostics Regulation (EU IVDR) presents a significant challenge for the healthcare ecosystem. Our team is dedicated to helping manufacturers navigate this complex landscape and ensure compliance with the relevant European laws.

Your key responsibilities will include conducting technical file reviews against the EU IVDR for Class A sterile, Class B, and Class C devices. You will verify compliance of technical documentation submitted by manufacturers against the regulatory requirements and identify, document, and seek to rectify instances where device technical files deviate from compliance.

In addition to your technical expertise, you will provide support for CE marking activities within SGS, contribute to the training and qualification of junior staff, and develop comprehensive training materials. Effective communication with team members, clients, and other stakeholders will be essential in minimizing regulatory risks associated with in vitro diagnostic device certification.

To be successful in this role, you will need to expand and keep up-to-date your knowledge of relevant technologies, regulations, international standards, and best practice guidance documents.

We are seeking an experienced candidate with at least 4 years of professional experience within the domain of healthcare products or related activities. A minimum of 2 years should involve direct engagement in the design, manufacture, testing, or utilization of specific in-vitro diagnostic devices and technologies, or relevant scientific research.


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