Clinical Product Specialist H/F

Affluent Medical is a French MedTech company specialized in the international development and industrialization of innovative, clinical-stage medical prostheses to treat urinary incontinence and mitral heart failure. The product portfolio currently includes 3 innovative prostheses: Artus : The first artificial sphincter activated by a remote control, for the treatment of moderate and severe urinary incontinence in men and women. Kalios : the only prosthesis for the repair of the cardiac mitral valve, which allows multiple post-operative readjustments of the mitral valve by transcatheter route without general anesthesia. Epygon : the only physiological cardiac bio prosthesis that mimics the native mitral valve and blood flow and can be implanted without "open heart" surgery. Their markets are global in scope and are expected to be worth more than €10 billion by 2027. As part of its development, we are looking for a: Clinical Product Specialist This job is based in Colleretto Giacosa, Italy.
Reporting to the CMO & VP Clin Affairs, the Clinical Product Specialist is the technical referent at the clinic service. Your role is transversal and involves providing technical support throughout the clinical testing process. You are a real interface for Epygon project with internal and external partners.
Tasks: Training (Simulands, IMRR) of new medical centers in the context of the clinical study Patients' eligibility evaluation within the context of clinical study using dedicated assessment software (e.g., Pie Medical 3mensio Structural Heart). Ad-hoc support to the clinical team in product-related training and technical questions and issues. Technical support during the clinical study (including transport and, Epygon TMV device preparation and crimping, data management). Case support : attending cases, crimping of the valve, setup logistics, … Coordination/Participation to preclinical activities Profile: You have a minimum of Biomedical/Clinical Master's Degree, with at least 2/3 years of working experience within class IIb or III medical devices environment, preferentially as clinical product specialist in cardiovascular. You have strong knowledge of ISO13485, 5840 and MDR and other related standards regulations for class IIB/III medical devices. You appreciate team working in multidisciplinary research groups and are comfortable in English. You have abilities to react quickly and effectively to challenging situations. You have a high level of autonomy and self-starting attitude with planning and organizational skills. Then, you have strong relational skills.


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