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

il y a 3 semaines


belgium SGS Temps plein

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:

  1. Conducting thorough technical documentation reviews of SaMD and devices using AI/Machine Learning (ML) and ensuring compliance with EU regulations and standards.
  2. Collaborating with cross-functional teams to increase efficiency and quality.
  3. Developing training and presenting the training to others in SGS or externally as deemed necessary.
  4. Project managing reviews as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards.
  5. Supporting/assisting on queries raised from the review.
  6. Working at all times to adhere to KPIs set as an individual and within a team.
  7. Ensuring personal competency is maintained to be able to review technical files and technical documentation.
  8. Ensuring that the highest level of service is provided throughout the SGS network offering medical device certification and stakeholders through efficient service delivery.

Qualifications

  1. Bachelor's degree in a related discipline (i.e., engineering or other relevant sciences).
  2. 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 (preferably in MDSW or other critical software requiring compliance with regulations) and AI/ML models in specific industry/academic research.
  3. 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.
  4. Knowledge and understanding of the related standards: IEC 62304, IEC 82304, IEC 81001-5-1, IEC 62366, etc.
  5. Thorough knowledge and understanding of AI regulations, released standards/guidance and AI/ML tools/libraries.
  6. Good written English skills (as reports will be reviewed/queried in English).
  7. 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.


Videos To Watch
https://www.youtube.com/watch?v=vso_LZuxki4

#J-18808-Ljbffr
  • Product Assessor

    il y a 3 semaines


    belgium SGS Temps plein

    Full-timeCompany DescriptionWe 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 DescriptionAre...


  • belgium Google Inc. Temps plein

    Embedded Software Engineering Manager, Silicon Platform Security SoftwareCompany: GoogleLocation: Mont-Saint-Guibert, BelgiumAdvancedExperience owning outcomes and decision making, solving ambiguous problems and influencing stakeholders; deep expertise in domain.Minimum Qualifications:Bachelor’s degree or equivalent practical experience.8 years of...

  • Senior Software Engineer .NET

    il y a 3 semaines


    belgium Agfa-Gevaert Temps plein

    Are you an expert in Software Development, ready to apply your skills in the exciting world of X-ray in radiology? To strengthen our diverse R&D team, we are looking for a motivated Software Development Expert.Tasks:Take ownership and responsibility from the start of the design, all the way to the successful implementation in real life radiology...


  • vlaanderen, belgium Flanders Make Temps plein

    You are building the next generation of cyber-physical systems. We inspire the industry by showing what we can do with the latest IIoT technology.Together with you, we will show on new prototype production lines how to capture data from end-to-end sources. It’s part of Flanders Make mission to guide companies towards the product life cycle of the future....

  • Software Engineer

    il y a 3 semaines


    belgium Acerta Temps plein

    The Belgian Centre for Pharmacotherapeutic Information (CBIP-BCFI) is a not-profit-making association founded in 1971 and approved by Royal Decree to provide medico-pharmaceutical information about medicinal products. The Board of Directors is composed of university medical faculties, scientific associations of physicians and pharmacists and a representative...


  • belgium Women in AI Temps plein

    WAI Belgium Community ManagerWe are excited to announce an opportunity for a passionate and dedicated individual to join our team as a Country Community Manager in Belgium. This volunteer position is ideal for someone who is enthusiastic about AI, committed to promoting diversity in tech, and has experience in building vibrant and engaged communities. As the...

  • Account Manager Flanders

    il y a 4 semaines


    belgium Michael Page International (Belgium) Temps plein

    Account Manager Flanders - Sales - Farming - Hunting - Medical Devices - NeuroHealthcare - Lifesciences - Intensive Care - Operating room - DU/ENGAbout Our ClientOur client is a globally recognised entity in the Healthcare industry presents in more than 100 countries around the globe. They produce and distribute Medical devices linked to Neurosurgery that...

  • Technology Consultant

    il y a 3 semaines


    belgium Proove BV Temps plein

    Proove has been growing internationally with projects in Belgium, France, Portugal, Norway... To reinforce our international presence, we are looking for a Technology Consultant that will become a true Proove ambassador.As Proovees, we are on a mission to change the way how complex projects are being managed by relying on data and data science. We work on...

  • Senior Software Engineer

    il y a 3 semaines


    belgium Robovision Temps plein

    Robovision is in hyper-growth! As an Artificial Intelligence Platform Provider (PaaS), our mission is to be the leading backbone of Vision AI. With an award-winning platform, operating in 40+ countries, Robovision is one of the global leaders in the provision of AI-vision.As part of our growth strategy, we are currently looking for new ambitious talent to...

  • C++ Software Engineer

    il y a 3 semaines


    belgium OMP Belgium Temps plein

    As a software engineer, you contribute to the creation of innovative and leading software solutions. Guided by our top-notch software architects and software experts, you participate in all the steps of the software development life cycle from analysis, architectural design, and programming to maintenance. You are proficient with your preferred technology,...

  • Software Architect

    il y a 4 semaines


    belgium, belgique WhatJobs Temps plein

    Luminex Network Intelligence is seeking a skilled and visionary Software Architect / Designer to join our talented team and contribute to the development of our cutting-edge technology. Taking up both roles, you will be the founder of a brand-new software platform that will serve as the back-end infrastructure at professional on-premise AVL networks,...

  • Software Engineer

    il y a 3 semaines


    belgium Trimble Inc. Temps plein

    Trimble is looking for a Medior Software Engineer for their Core Product Development team in Leuven, Belgium. In this role, you will be involved in the design and development of solutions based on Java, J2EE, and MicroServices technologies, and will also work on enhancing and adding new features to the various software products developed by Trimble Transport...

  • Software Architect

    il y a 3 semaines


    belgium, belgique WhatJobs Temps plein

    Nalys is a consulting group dedicated to high technology projects. Thanks to our strong corporate values and adhocracy management, we are one of the fastest growing actors in engineering consultancy. We gather great minds & challenge boundaries to help our customers develop stunning products. And we love doing it. Responsibilities You help shape and define...


  • belgium Syneos Health, Inc. Temps plein

    Updated: September 4, 2024Location: Europe-BelgiumJob ID: 24004628For one of our sponsors, we are currently looking for a Site Activation Specialist to join this single sponsor role.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and...

  • R&D Manager

    il y a 3 semaines


    belgium Marketing - Product Specialist (MW) Temps plein

    Flen Health is an international family-owned company with ambitious growth plans in the pharmaceutical and medical device technological domain. Flen Health has a range of products for wound and skin care, several new products in the pipeline and research cooperation agreements in Europe and the USA.At Flen Health, we focus on people with topical inflammatory...

  • Software Engineering Manager

    il y a 3 semaines


    belgium Paratus People Temps plein

    Software Engineer ManagerPermanentCandidates from NL / BE will be considered as our client has offices in both countries.Very Competitive PackageEmbedded Software Leads we want you to lead our client’s development team. You’ll be working on the development of state-of-the-art embedded software systems as they secure their spot as a world leader in...


  • brussels region, belgium, belgium Exsolvæ Temps plein

    About Exsolvæ:Exsolvæ is a Brussels-based consultancy at the forefront of Data and Artificial Intelligence innovation. We specialize in providing expert Consultancy, Audit, and Solution Development services to empower our partners in overcoming unique challenges. Our holistic approach fosters collaboration across diverse domains, including Business...

  • IT Applications Lead

    il y a 3 semaines


    belgium Axelera AI Temps plein

    About UsAxelera AI is not your regular deep-tech startup. We are creating the next-generation AI platform to support anyone who wants to help advancing humanity and improve the world around us. In just three years, we have raised a total of $120 million and have built a world-class team of 180+ employees (including 55+ PhDs with more than 40,000 citations),...


  • belgium Vlaamse Technische Kring vzw Temps plein

    Research Engineer Computer Vision & Machine Learning (Leuven or Lommel or Kortrijk)Work on the state of the art of computer vision and machine learning technologies for the factory of the future. Discuss great project ideas in your team and inspire others with your experience.For a variety of real industry cases, we want to increase the intelligence and...

  • Product Manager

    il y a 3 semaines


    belgium The CRC SmartWasher Temps plein

    The role of the Product Manager is to be subject matter expert for the assigned products/segments. This position is responsible for developing and maintaining product profitability, positioning, placement & promotional activities for assigned product families.Some tasks that await you:Develop and implement multi-year product marketing plan including...