Product Assessor

hace 3 días

Madrid, Madrid, España Sgs A tiempo completo
Job Description

As 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 the new European In Vitro Diagnostics Regulation.

Your role will involve assessing in-vitro diagnostic medical devices for strict compliance with the relevant European laws (EU IVDR; Regulation 2017/746).

You will 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, verifying compliance of technical documentation submitted by manufacturers against the regulatory requirements.

You will identify, document and seek to rectify instances where device technical files deviate from compliance with applicable requirements under the IVDR.

You will provide support for CE marking activities within SGS, contribute to the training and qualification of junior staff, and develop comprehensive training materials.

You will 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.

Key Responsibilities
  1. 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.
  2. Identify, document and seek to rectify instances where device technical files deviate from compliance with applicable requirements under the IVDR.
  3. Provide support for CE marking activities within SGS.
  4. Contribute to the training and qualification of junior staff.
  5. Develop comprehensive training materials.
  6. Communicate effectively with team members, clients, and other stakeholders regarding product assessments.
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.
  • Proficient communication skills using modern electronic platforms.
  • Strong written English skills, as reports will be reviewed and queried in English.
  • Demonstrated skills in independent learning.
Desirable Skills
  • 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.
  • A 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.
  • An in-depth knowledge of the European regulatory framework on medical devices is highly advantageous, but is not required to apply for this role as on-the-job training will be provided.

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