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

Company Description

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. 

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 (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 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.

Additional Information

Why SGS?

  • Join a globally recognized and stable company, a leader in the Testing, Inspection, and Certification (TIC) industry.
  • Enjoy a flexible schedule and remote work model.
  • Access SGS University and Campus for continuous learning options.
  • Thrive in a multinational environment, collaborating with colleagues from multiple continents.
  • Benefit from our comprehensive benefits platform.

Join Us: At SGS, we are dedicated to fostering an open, friendly, and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn, grow your expertise, and fulfill your potential. 

What You Should Know About Software (SaMD) & Artificial intelligence (AI) Product Assessor - Active Devices, SGS

Are you an expert in software assessment looking to take your career to the next level? Join SGS as a Software (SaMD) & Artificial Intelligence (AI) Product Assessor based in our lively office in Industrie, Italy. At SGS, the world-leader in testing and certification, we are on the lookout for a driven professional with a robust background in healthcare products and compliance. You'll dive into the exciting world of software as a medical device, conducting in-depth reviews of technical documentation. Your role is pivotal as you'll ensure that our products meet rigorous EU regulations and standards. Collaboration is key; you'll work closely with cross-functional teams to enhance efficiency and quality while managing projects to boost client satisfaction. Your duties also include developing and presenting training for both internal teams and external stakeholders, further showcasing your expertise. With a Bachelor’s degree in a related field and four years of relevant experience, including two in software development and AI, you’re equipped to tackle the Software Life Cycle processes. At SGS, where innovation meets integrity, you'll enjoy a flexible work schedule and continual learning opportunities while contributing to making the world a safer, more interconnected place.

Frequently Asked Questions (FAQs) for Software (SaMD) & Artificial intelligence (AI) Product Assessor - Active Devices Role at SGS
What are the main responsibilities of a Software (SaMD) & AI Product Assessor at SGS?

As a Software (SaMD) & AI Product Assessor at SGS, your responsibilities include conducting thorough technical documentation reviews of software as a medical device and AI applications, ensuring compliance with EU regulations. You'll collaborate with various teams to enhance service delivery and client satisfaction, project manage reviews, and provide training to internal and external stakeholders.

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What qualifications are needed for the Software (SaMD) & AI Product Assessor position at SGS?

To qualify for the Software (SaMD) & AI Product Assessor position at SGS, candidates must hold a Bachelor’s degree in a relevant discipline and have at least four years of experience in healthcare products. This includes at least two years focused on developing SaMD, as well as a strong grasp of programming languages and AI/ML knowledge.

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How does SGS support the professional development of Software (SaMD) & AI Product Assessors?

SGS encourages continuous professional development for Software (SaMD) & AI Product Assessors through access to SGS University and various training programs. Employees can expand their expertise and leadership skills, positioning themselves for future career growth within the company.

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What is the work environment like for a Software (SaMD) & AI Product Assessor at SGS?

The work environment for a Software (SaMD) & AI Product Assessor at SGS is dynamic and collaborative. You'll be part of a multicultural team, working on cutting-edge projects that have a real impact on the healthcare industry while enjoying a flexible schedule and remote work options.

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What key skills are essential for a Software (SaMD) & AI Product Assessor at SGS?

Essential skills for a Software (SaMD) & AI Product Assessor at SGS include a solid understanding of software life cycle processes, proficiency in programming languages, and knowledge of AI regulations and standards. Effective communication and project management abilities are also critical for success in this role.

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Common Interview Questions for Software (SaMD) & Artificial intelligence (AI) Product Assessor - Active Devices
Can you explain your experience with the Software Life Cycle processes?

In an interview, you can elaborate on your hands-on experiences with requirement analysis, design, coding, and testing phases, highlighting specific projects where you successfully implemented these processes. This displays your familiarity with managing the software development phases effectively.

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How do you ensure compliance with EU regulations when assessing software products?

You should discuss the steps you take to stay informed about EU regulations, detail your review processes, and illustrate how you address areas that typically pose compliance challenges. Emphasizing a proactive approach is beneficial.

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What challenges have you faced in reviewing SaMD documentation, and how did you overcome them?

Here, share a specific challenge related to a project and the strategies you utilized to overcome it, emphasizing your problem-solving skills and adaptability, which are crucial for a Software (SaMD) & AI Product Assessor.

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Describe a time when you had to lead a training session on regulatory compliance.

Provide an example where you effectively prepared and delivered training, focusing on engagement techniques and how you tailored the content for the audience. This showcases your leadership and communication skills.

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What programming languages are you proficient in, and how have you applied them in past projects?

Discuss your experience with specific programming languages relevant to the role, providing clear examples of how you applied them to achieve results, especially emphasizing compliance and developing software in regulated environments.

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How do you stay current with the latest AI and software regulations?

Explain your methods for keeping up with new regulations, such as attending workshops, participating in webinars, or being a member of professional organizations. This shows your commitment to continuous learning and professional development.

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Can you provide an example of a project where you successfully managed cross-functional collaboration?

Share details of a specific project highlighting how you facilitated communication among different teams, the outcomes of that collaboration, and the impact it had on project success, demonstrating your teamwork skills.

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What metrics do you use to assess the quality of technical documentation?

Discuss specific key performance indicators (KPIs) you focus on when evaluating technical documentation, as well as how you ensure that documentation meets high standards of quality and compliance.

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Why do you want to work for SGS as a Software (SaMD) & AI Product Assessor?

In your response, align your personal values with SGS’s mission of quality and integrity and express your enthusiasm about contributing to their impactful work in the healthcare sector.

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What methods do you use for root cause analysis when troubleshooting software issues?

Detail the techniques and tools you use for root cause analysis, emphasizing your systematic approach to identifying and resolving software issues, showcasing both your analytical skills and technical knowledge.

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SGS is an inspection, verification, testing, and certification company. The company inspects agricultural products, minerals, petroleum and petrochemicals, motor vehicles, and consumer goods. SGS is headquartered in Geneva, Switzerland.

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Full-time, remote
DATE POSTED
January 13, 2025

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