IVDR Product Assessor
il y a 1 semaine
As a highly skilled IVDR Product Assessor, you will play a critical role in ensuring the safe and effective use of in-vitro diagnostic medical devices across Europe. With a strong background in clinical diagnostic technologies, you will be responsible for assessing technical documentation submitted by manufacturers to verify compliance with the EU In-vitro Diagnostics Regulation.
Key Responsibilities:
- Conduct thorough reviews of technical files against the EU IVDR for Class A sterile, Class B, and Class C devices, ensuring compliance with regulatory requirements.
- Identify and document deviations from compliance and work to rectify instances where device technical files do not meet applicable requirements.
- 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 stakeholders regarding product assessments, minimizing regulatory risks associated with in vitro diagnostic device certification.
- Stay up-to-date with relevant technologies, regulations, international standards, and best practice guidance documents.
Requirements:
- At least 4 years of professional experience in the domain of healthcare products or related activities, with a minimum of 2 years involving direct engagement in the design, manufacture, testing, or utilization of specific in-vitro diagnostic devices and technologies.
- 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 on-the-job training will be provided.
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