Clinical Specialist

• Checking and reporting compliance of clinical studies and reports in the technical files of the customer communicated to them by Kiwa
• Current training on clinical evaluation. Tracking the information and documents sent by Kiwa
• Monitoring and sharing of legal legislation and guide documents related to clinical evaluation published by the EU and Ministry of health
• Monitoring and sharing of negative events and recall notifications published by the EU, FDA and Ministry of health and sharing with Kiwa
• Evaluation of new applications submitted by Kiwa and reporting of opinions

• Graduated from Faculty of Medicine or Faculty of Dentistry
• Work experience in clinical practice with a duration of at least 4 years, related to the use of the medical device or similar products, to the knowledge of the pathology of the condition to be treated and to the relative alternative treatments in relation to the devices and to other products. The person must be currently employed in the field.
• Knowledge of the current legislation (EU Regulation 2017/745, provisions established by control bodies, etc.) governing medical devices, including the performance and safety requirements set out in Annex I of the MDRMDR which can be demonstrated through relevant work experience or training with a duration of at least 16 hours.
• Adequate knowledge and experience pertaining to the harmonised standards, of Common Specifications (CS) and relevant guidelines (e.g. ISO 14155, MeddevMeddev 2.7.X, MDCGMDCG, etc.), that regulate the medical devices sector, which can be demonstrated through work experience and training with a duration of at least 16 hours.
• Knowledge of the relevant KiwaKiwa TR procedures related to clinical data evaluation, demonstrated by specific training conducted by KiwaKiwa TR.
• Ability to draft records and reports, with the correct performance of the relevant clinical evaluation activities, which can be demonstrated through work experience with a notified body.

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