IVDR Product Assessor
hace 1 mes
We are SGS – the world's leading testing, inspection and certification company. Our mission is to create a better, safer and connected world by supporting, improving or augmenting our physical operations with digital technologies.
Job DescriptionAs an IVDR Product Assessor, you will use your skills as an expert in clinical diagnostic technologies to ensure that patients across Europe have access to safe and effective diagnostic tests. You will be part of our rapidly growing team of regulatory professionals in helping the European healthcare ecosystem navigate the challenging transition to the new European In Vitro Diagnostics Regulation.
Key Responsibilities:- Conduct technical file reviews against the EU In-vitro Diagnostics Regulation for Class A sterile, Class B and Class C devices within a defined timeframe, by verifying compliance of technical documentation submitted by manufacturers against the regulatory requirements.
- Identify, document and seek to rectify instances where device technical files deviate from compliance with applicable requirements under the IVDR.
- Provide support for CE marking activities within SGS, contribute to the training and qualification of junior staff, and develop comprehensive training materials.
- Communicate effectively with team members, clients, and other stakeholders regarding product assessments, working diligently to minimize regulatory risks associated with in vitro diagnostic device certification.
- Expand and keep up-to-date your knowledge of relevant technologies, regulations, international standards and best practice guidance documents.
We are seeking an experienced candidate with:
- At least 4 years of professional experience within the domain of healthcare products or in related activities.
- A minimum of 2 years involving direct engagement in the design, manufacture, testing or utilization of specific in-vitro diagnostic devices and technologies, or relevant scientific research.
- Knowledge encompassing a range of IVR/IVS/IVP/IVD competence codes for IVDR, as defined in Commission implementing regulation (EU) 2017/2185.
- Degree or equivalent qualification in a relevant technical discipline such as medicine, engineering, biomedical science, microbiology or biochemistry.
- Strong written English skills, as reports will be reviewed and queried in English.
- Demonstrated skills in independent learning.
- Direct experience with medical device development life cycle processes, regulatory submissions and relevant standards such as ISO 13485 and ISO 14971.
- Experience with clinical studies and clinical performance evaluation of in-vitro diagnostic devices.
- Broad base of experience covering a variety of different diagnostic assay types and technologies.
- Prior experience in conducting product technical documentation assessments for another Conformity Assessment Body / Notified Body (technical file reviewer or equivalent role) would be considered advantageous.
We value diversity and provide endless opportunities to learn, grow your expertise, and fulfill your potential.
-
IVDR Product Assessor
hace 1 mes
Madrid, Madrid, España Sgs Société Générale De Surveillance A tiempo completoAt SGS, we are seeking an experienced IVDR Product Assessor to join our team of regulatory professionals. As an expert in clinical diagnostic technologies, you will play a crucial role in ensuring that patients across Europe have access to safe and effective diagnostic tests.The European In Vitro Diagnostics Regulation (EU IVDR) presents a significant...
-
Product Assessor
hace 1 mes
Madrid, Madrid, España Sgs A tiempo completoJob DescriptionAs an IVDR Product Assessor at SGS, you will leverage your expertise in clinical diagnostic technologies to ensure patients across Europe have access to safe and effective diagnostic tests.You will be part of our rapidly growing team of regulatory professionals, helping the European healthcare ecosystem navigate the challenging transition to...
-
Senior Product Assessor
hace 1 mes
Madrid, Madrid, España Sgs A tiempo completoJob Title: Senior Product AssessorAbout the Role:We are seeking a highly skilled Senior Product Assessor to join our dynamic team at SGS. As a Senior Product Assessor, you will be responsible for conducting thorough technical documentation reviews and ensuring compliance with EU regulations and standards.Key Responsibilities:Supporting and guiding a team of...
-
Software Product Assessor
hace 7 días
Madrid, Madrid, España SGS A tiempo completoSoftware Product Assessor RoleWe are seeking a highly skilled Software Product Assessor to join our dynamic team at SGS.This exciting opportunity will allow you to leverage your expertise in software development and regulatory compliance to ensure that medical device software meets the required standards.
-
Senior Product Assessor
hace 1 mes
Madrid, Madrid, España Sgs Société Générale De Surveillance Sa. A tiempo completoAre you a seasoned Product Assessor looking to take your career to the next level? We have an exciting opportunity for a Senior Product Assessor - Active Devices to join our dynamic team at SGS.This role will allow you to make a significant impact in the field of certification. Your responsibilities will include:Supporting and guiding a team of talented...
-
Product Regulatory Specialist
hace 1 mes
Madrid, Madrid, España Sgs Société Générale De Surveillance Sa. A tiempo completoWe are SGS – the world's leading testing, inspection and certification company. Our mission is to create a better, safer and connected world by supporting, improving or augmenting our physical operations with digital technologies.As an IVDR Product Assessor, you will use your skills as an expert in clinical diagnostic technologies to ensure that patients...
-
Product Regulatory Specialist
hace 1 mes
Madrid, Madrid, España Sgs A tiempo completoProduct Regulatory SpecialistAt SGS, we are seeking an experienced Product Regulatory Specialist to join our team of regulatory professionals. As an IVDR Product Assessor, you will play a crucial role in ensuring the compliance of in-vitro diagnostic medical devices with the European In Vitro Diagnostics Regulation (IVDR).Your key responsibilities will...
-
Senior Product Assessor
hace 1 mes
Madrid, Madrid, España Sgs Société Générale De Surveillance Sa. A tiempo completoSenior Product Assessor - Active Devices SpecialistAbout the RoleWe are seeking a highly skilled Senior Product Assessor - Active Devices Specialist to join our team at SGS. As a key member of our team, you will be responsible for conducting thorough technical documentation reviews and ensuring compliance with EU regulations and standards.Key...
-
Madrid, Madrid, España Page Personnel A tiempo completoJoin Our Medical Device TeamPage Personnel is seeking a highly skilled Product Assessor Technical Specialist to join our team.This is a permanent position in a world reference company, offering a unique opportunity to work with a global leader in quality.As a Product Assessor Technical Specialist, you will be responsible for conducting thorough technical...
-
Senior Product Assessor
hace 2 semanas
Madrid, Madrid, España Sgs A tiempo completoSenior Product Assessor - Active DevicesWe 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...
-
Software Product Assessor
hace 4 semanas
Madrid, Madrid, España SGS A tiempo completoSoftware Product Assessor RoleWe are seeking a highly skilled Software Product Assessor to join our team at SGS. As a Software Product Assessor, you will be responsible for conducting thorough technical documentation reviews of SaMD and devices using AI/Machine Learning (ML) and ensuring compliance with EU regulations and standards.Key...
-
Senior Product Specialist
hace 7 días
Madrid, Madrid, España SGS A tiempo completoAbout the RoleWe are seeking a highly skilled Senior Product Assessor to join our dynamic team at SGS. As a Senior Product Assessor, you will play a key role in ensuring compliance with EU regulations and standards.Key ResponsibilitiesSupport and guide your team of Product Assessors in conducting thorough technical documentation reviews.Collaborate with...
-
Software and AI Product Assessor
hace 1 mes
Madrid, Madrid, España Sgs A tiempo completoSoftware and AI Product Assessor - Active DevicesWe are SGS, the world's leading testing, inspection and certification company. Our mission is to enable a better, safer and more interconnected world. As a Software and AI Product Assessor, you will play a crucial role in ensuring the quality and integrity of medical devices and software solutions.Your...
-
Assessor/A Comercial Senior
hace 1 mes
Madrid, Madrid, España Mgs S.A A tiempo completoDescripció del càrrec: Buscamos un/a Assessor/A Comercial per a unir-se a un projecte consolidat dins l'entitat. La persona seleccionada formarà part d'un pla de carrera estable i a llarg termini, desenvolupant accions comercials per a la generació de noves vendes de productes asseguradors. Responsabilitats: - Assessorar a clients en funció de les seves...
-
Madrid, Madrid, España Sgs Société Générale De Surveillance Sa. A tiempo completoSoftware and Artificial Intelligence Product Assessor - Active DevicesWe are SGS, the world's leading testing, inspection and certification company. Our mission is to enable a better, safer and more interconnected world. Job DescriptionAs a Product Assessor for Software and AI, you will play a key role in ensuring the quality and safety of medical devices....
-
Product Certification Expert
hace 7 días
Madrid, Madrid, España SGS A tiempo completoSenior Product Assessor Job SummaryThe Senior Product Assessor will be responsible for leading a team of Product Assessors in reviewing technical documentation and ensuring compliance with EU regulations and standards.About UsSGS is a world-leading Testing, Inspection, and Certification company with a network of 2,600 offices and laboratories...
-
Product Assessor
hace 1 mes
Madrid, Madrid, España SGS A tiempo completoJob OverviewAs a Product Assessor at SGS, you will play a crucial role in ensuring the technical file reviews of Cardiovascular and Soft Tissue products adhere to all applicable requirements, including the European Medical Device Regulation (MDR), Medical Device Directive (MDD), and UKCA for Class IIa/IIb and/or Class III devices.Your responsibilities will...
-
Assessor/a Comercial de Vehícules de Projecció
hace 7 días
Madrid, Madrid, España Grup Mibec Lleida S.L. A tiempo completo**Empresa líder en el sector automoció de Lleida busca a un/a assessor/a comercial con experiencia para incorporarse al equip de vendes.**Detalls del lloc de treball:La empresa es referent en el sector automoció de Lleida, amb una gran experiència en la gestió de clients i vehícles.**Funcions:S'encarregarà de l'argumentació tècnica i comercial del...
-
Product Assessment Lead
hace 6 días
Madrid, Madrid, España SGS Société Générale de Surveillance SA. A tiempo completoWe are seeking an experienced Product Assessment Lead to join our dynamic team at SGS. This role will allow you to make a significant impact in the field of certification.Your responsibilities will include:Supporting and guiding your team of talented product assessorsConducting thorough technical documentation reviews and ensuring compliance with EU...
-
Product Assessment Specialist
hace 1 semana
Madrid, Madrid, España Sgs Société Générale De Surveillance Sa. A tiempo completoJob DescriptionWe are SGS, a world-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.About the RoleWe are seeking a...