IVDR Product Assessor

hace 16 horas


Madrid, Madrid, España Sgs Société Générale De Surveillance A tiempo completo
Job Title: IVDR Product Assessor

Sgs Société Générale De Surveillance is seeking an experienced IVDR Product Assessor to join our team. As an IVDR Product Assessor, you will play a critical role in ensuring the safety and effectiveness of in-vitro diagnostic medical devices in the European market.

Key Responsibilities:
  • Conduct technical file reviews against the EU In-vitro Diagnostics Regulation for Class A sterile, Class B and Class C devices within a defined timeframe.
  • 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, contribute to the training and qualification of junior staff, and develop comprehensive training materials.
  • Communicate effectively with team members, clients, and other stakeholders regarding product assessments, working diligently to minimize regulatory risks associated with in vitro diagnostic device certification.
Requirements:
  • At least 4 years of professional experience within the domain of healthcare products or in 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.

Sgs Société Générale De Surveillance is a leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our mission is to create a better, safer and connected world by supporting, improving or augmenting our physical operations with digital technologies.


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