IVDR Product Assessor

hace 1 mes


Madrid, Madrid, España Sgs Société Générale De Surveillance Sa. A tiempo completo

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 Description

As 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.
Qualifications

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.



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