Senior Regulatory Specialist for In-Vitro Diagnostics

Há 1 mês


Lisboa, Lisboa, Portugal Buscojobs Portugal Tempo inteiro

At Buscojobs Portugal, we're seeking a seasoned professional to lead our team in ensuring the compliance of in-vitro diagnostic medical devices with the EU IVDR. As a Senior Regulatory Specialist for In-Vitro Diagnostics, you will be responsible for conducting technical file reviews against the EU In-vitro Diagnostics Regulation for Class A sterile, Class B and Class C devices.

The ideal candidate will have at least 4 years of experience within the domain of healthcare products or related activities, including roles in design and development, manufacturing, auditing, relevant academic research, or work in a clinical setting. Direct engagement in the design, manufacture, testing or utilization of specific in-vitro diagnostic devices and technologies, or relevant scientific research is required.

We offer a competitive salary of around €60,000 per year, flexible schedule, fully remote work model, access to SGS University and Campus for continuous learning options, and a comprehensive benefits platform.

This role involves:

  • Conducting technical file reviews against the EU In-vitro Diagnostics Regulation for Class A sterile, Class B and Class C devices.
  • Identifying, documenting and seeking to rectify instances where device technical files deviate from compliance with applicable requirements under the IVDR.
  • Providing support for CE marking activities within SGS, contributing to the training and qualification of junior staff, and developing comprehensive training materials.
  • Communicating effectively with team members, clients, and other stakeholders regarding product assessments, working diligently to minimize regulatory risks associated with in vitro diagnostic device certification.

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