Product Evaluator for Software and Artificial Intelligence Devices

hace 4 semanas


Madrid, Madrid, España Sgs A tiempo completo

Company Overview

We are SGS, the world's leading testing and certification company. Our mission is to enable a better, safer, and more connected world through our work.

Job Description

We are seeking a highly skilled Product Evaluator to join our team. As a Product Evaluator, you will be responsible for conducting thorough technical documentation reviews of SaMD and devices using AI/Machine Learning (ML) and ensuring compliance with EU regulations and standards.

Your Key Responsibilities

  • Conduct technical documentation reviews of SaMD and devices to ensure compliance with EU regulations and standards.
  • Collaborate with cross-functional teams to increase efficiency and quality.
  • Develop and present training to others in SGS or externally as needed.
  • Project manage reviews to maximize efficiencies, enhance client satisfaction, and ensure compliance with standards.
  • Support and assist on queries raised from reviews.
  • Maintain personal competency to review technical files and technical documentation.

Requirements

  • Bachelor's degree in a related discipline (e.g., engineering, or other relevant sciences).
  • Four years of professional experience in the field of healthcare products or related activities, such as design, manufacturing, auditing, or research.
  • Thorough knowledge and understanding of the Software Life Cycle processes.
  • Knowledge and understanding of AI regulations, released standards/guidance, and AI/ML tools/libraries.
  • Good written English skills (as reports will be reviewed/queried in English).

Additional Information

  • Knowledge of the following Technical File codes desirable (COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017) MDS1009 and MDS0315.


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