IVDR Product Assessor

6 giorni fa


Milano, Lombardia, Italia SGS A tempo pieno
Job Title: IVDR Product Assessor

At SGS, we are seeking an experienced Regulatory Expert to join our team of professionals in the field of In-Vitro Diagnostics. As an IVDR Product Assessor, you will play a crucial role in ensuring the compliance of medical devices with the European In Vitro Diagnostics Regulation (IVDR).

Key Responsibilities:
  • Conduct technical file reviews of in-vitro diagnostic medical devices to verify compliance with the EU IVDR.
  • Identify and document deviations from compliance and work with manufacturers to rectify these issues.
  • Provide support for CE marking activities and contribute to the training and qualification of junior staff.
  • Communicate effectively with team members, clients, and stakeholders regarding product assessments.
  • Stay up-to-date with relevant technologies, regulations, and best practices in the field of In-Vitro Diagnostics.
Qualifications:
  • At least 4 years of professional experience in the healthcare industry or related activities.
  • Minimum 2 years of experience in the design, manufacture, testing, or utilization of in-vitro diagnostic devices and technologies.
  • Knowledge of IVR/IVS/IVP/IVD competence codes for IVDR.
  • Degree or equivalent qualification in a relevant technical discipline.
  • Strong written English skills and proficient communication skills using modern electronic platforms.
Desirable Skills:
  • Experience with medical device development life cycle processes and regulatory submissions.
  • Knowledge of ISO 13485 and ISO 14971 standards.
  • Experience with clinical studies and clinical performance evaluation of in-vitro diagnostic devices.
  • Prior experience in conducting product technical documentation assessments for a Conformity Assessment Body or Notified Body.

At SGS, we offer a dynamic and supportive work environment, flexible schedule, and comprehensive benefits platform. If you are passionate about regulatory compliance and In-Vitro Diagnostics, we encourage you to apply for this exciting opportunity.


  • Senior Product Assessor

    1 settimana fa


    Milano, Lombardia, Italia SGS A tempo pieno

    Job Title: Senior Product Assessor - Active DevicesWe are seeking a highly skilled and experienced Senior Product Assessor to join our dynamic team at SGS. As a Senior Product Assessor, you will play a key role in ensuring the highest level of service is provided throughout the SGS network, offering medical devices certification and stakeholders through...


  • Milano, Lombardia, Italia SGS A tempo pieno

    Job Title: Senior Product Assessor - Active DevicesWe are seeking a highly skilled and experienced Senior Product Assessor to join our dynamic team at SGS. As a Senior Product Assessor, you will play a key role in ensuring the highest level of service is provided throughout the SGS network, offering medical devices certification and stakeholders through...

  • Senior Product Assessor

    3 settimane fa


    Milano, Lombardia, Italia SGS A tempo pieno

    Job Title: Senior Product Assessor - Active DevicesWe are seeking a highly skilled and experienced Senior Product Assessor to join our dynamic team at SGS. As a Senior Product Assessor, you will play a key role in ensuring the highest level of service is provided throughout the SGS network, offering medical devices certification and stakeholders through...


  • Milano, Lombardia, Italia SGS A tempo pieno

    Job Title: Senior Product Assessor - Active DevicesWe are seeking a highly skilled and experienced Senior Product Assessor to join our dynamic team at SGS. As a Senior Product Assessor, you will play a key role in ensuring the highest level of service is provided throughout the SGS network, offering medical devices certification and stakeholders through...


  • Milano, Lombardia, Italia Abbott A tempo pieno

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Abbott. In this role, you will be responsible for creating and updating Quality Management System (QMS) documentation, participating in product development projects, and supervising quality aspects in product installation and servicing activities.Key...

  • Ivdr Product Assessor

    3 giorni fa


    Milano, Italia Tn Italy A tempo pieno

    col-wideJob Description:Job DescriptionAs anIVDR Product Assessor, you will use your skills as an expert inclinical diagnostic technologiesto ensure that patients across Europe have access to safe and effective diagnostic tests. Join our rapidly growing team of regulatory professionals in helping the European healthcare ecosystem navigate the challenging...

  • Senior Product Assessor

    3 settimane fa


    Milano, Italia Sgs A tempo pieno

    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...


  • Provincia di Milano, Lombardia, Italia IMQ spa A tempo pieno

    IMQ rappresenta una delle più importanti realtà italiane nel settore della valutazione della conformità. Forti dell'esperienza maturata in quasi 70 anni di attività, ci poniamo come partner ideale delle aziende, delle organizzazioni e dei professionisti che vogliono valorizzarsi certificando la sicurezza, la qualità e le prestazioni dei propri prodotti...


  • Provincia di Milano, Lombardia, Italia IMQ spa A tempo pieno

    IMQ rappresenta una delle più importanti realtà italiane nel settore della valutazione della conformità. Forte dell'esperienza maturata in quasi 70 anni di attività, si pone come partner ideale di coloro che vogliono valorizzarsi certificando la sicurezza, la qualità e le prestazioni dei propri prodotti e del proprio operato. Offriamo servizi di...

  • Senior Product Assessor

    2 settimane fa


    Milano, Italia Tn Italy A tempo pieno

    col-wideJob Description:Job DescriptionAre you ready totake your career to the next level? If you have a strong background as aProduct Assessorwithin an EUnotified bodyconducting MDD/MDR technical documentation review, then we have anexhilarating opportunityfor you!Join ourdynamic team at SGSand become aSenior Product Assessor - Active Devices. This role...

  • Product Assesor

    4 mesi fa


    Milano, Italia SGS A tempo pieno

    **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. As a **Product...


  • Milano, Italia Bureau Veritas A tempo pieno

    **CAREERS** Bureau Veritas LCIE Cybersecurity lab is growing steadily and is looking for new colleagues to expand and strengthen our team of passionate cybersecurity specialists. We are looking for variety of profiles from beginners willing to learn and expand their cybersecurity experience to confirmed professionals & experts looking for new...


  • Milano, Italia EcoLab A tempo pieno

    Ecolab is seeking a **Brand Protection Advisor **to join its EcoSure division, an industry leader in brand protection programs, to drive operational excellence and help our clients grow their business. Our associates are valued experts in brand standards, guest experience, food safety, public health, workplace safety, and product quality. EcoSure clients...


  • Milano, Italia Tn Italy A tempo pieno

    col-wideJob Description:JOB DESCRIPTIONEcolab is seeking aBrand Protection Advisorto join its EcoSure division, an industry leader in brand protection programs, to drive operational excellence and help our clients grow their business. Our associates are valued experts in brand standards, guest experience, food safety, public health, workplace safety, and...