Software (SaMD) & Artificial Intelligence (AI) Product Assessor - Active Devices Full-time
We are SGS – the world's leading testing, inspection and certification company.
We are recognized as the global benchmark for sustainability, quality and integrity.
Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.
Are you ready to take your career to the next level?
If you have a strong background as a Product Assessor within an EU notified body conducting MDS technical documentation review, then we have an exhilarating opportunity for you!
Join our dynamic team at SGS and become a Software & AI Product Assessor.
This role will allow you to make a significant impact in the field of certification.
Your responsibilities will include:
Conducting thorough technical documentation reviews of SaMD and devices using AI/Machine Learning (ML) and ensuring compliance with EU regulations and standards. Collaborating with cross-functional teams to increase efficiency and quality. Developing training and presenting the training to others in SGS or externally as deemed necessary. Project managing reviews as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. Supporting/assisting on queries raised from the review. Working at all times to adhere to KPI's set as an individual and within a team. Ensuring personal competency is maintained to be able to review technical files and technical documentation. Ensuring that the highest level of service is provided throughout the SGS network offering medical devices certification and stakeholders through efficient service delivery. Minimum Requirements: Bachelor's degree in a related discipline (i.e., 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, of which two years shall be in developing SaMD demonstrating knowledge of one or more programming languages (preferable in MDSW or other critical software requiring compliance with regulations) and AI/ML models in specific industry/academic research. Thorough knowledge and understanding of the Software Life Cycle processes: requirement analysis, design and coding, configuration management including version and change control, testing including unit, integration, regression and system testing, validation and release, and problem resolution techniques including debugging techniques, root cause analysis and code reviews. Knowledge and understanding of the related standards: IEC 62304, IEC 82304, IEC 81001-5-1, IEC 62366, etc. Thorough 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).
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