Software (SaMD) & Artificial intelligence (AI) Product Assessor - Active Devices

3 weeks ago

Mumbai, India SGS Full time
Job Description

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 Develop training and present the training to others in SGS or externally as deemed necessary. Project manage reviews as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standard Support/assist on queries raised from the review Work at all times to adhere to KPI’s set as an individual and within a team Ensure personal competency is maintained to be able to review technical files and technical documentation Ensure that the highest level of service is provided throughout the SGS network offering medical devices certification and stakeholders through efficient service delivery.

Qualifications

Bachelor’s degree in a related discipline (, 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); 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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