IVDR Product Assessor

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. Join 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. 

Your role will be to  assess in-vitro diagnostic medical devices  for strict compliance with the relevant European laws ( EU IVDR; Regulation 2017/746 ). You key task will be carrying out reviews of the manufacturers'  technical documentation  as part of the  CE marking  process. This will require a keen interest in and deep understanding of the product technologies being assessed, knowledge of the clinical application of the devices, as well as a keen eye for detail.

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 staf f, 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. This may include for example roles in design and development, manufacturing, auditing, relevant academic research, or work in a clinical these, a minimum of  2 years  should involve 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 d iagnostic 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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