Clinical Specialist

A global leader in the sports medicine market and experiencing strong growth, we offer innovative solutions based on cutting‑edge technologies. As part of our development, we are recruiting a Clinical Affairs Specialist (M / F).Reporting to the R&D – Clinical Affairs Department, your main responsibilities will include :Scientific and Competitive IntelligenceResearch, analysis, synthesis, and monitoring of clinical and scientific literature related to the company’s productsResearch on techniques, safety, efficacy, and performance of competitors’ productsMaintenance of the bibliographic database and analysis of new clinical dataClinical Safety DocumentationDrafting of Clinical Evaluation Reports (CER) in accordance with MEDDEV 2.7 / 1Implementation and execution of PMCF (Post-Market Clinical Follow‑up) studiesSupport for Post‑Market Surveillance (PMS) activitiesClinical StudiesDrafting documentation related to clinical studiesDevelopment of protocols to monitor product performance and safety in a clinical contextDrafting follow‑up questionnairesAnalysis of resultsCollaboration with CROsManagement of clinical studiesRegulatory AffairsSupport the Regulatory Affairs team in product registration processes in Europe and internationallyAssist in drafting Clinical Evaluation Reports (CER) and Clinical Development Plans (CDP), among othersProfile SoughtBiomedical engineer or graduate in Health Sciences or a biomedical‑related fieldMinimum 5 years of experience in clinical and regulatory affairs related to medical devices, ideally diagnostic support software for medical imagingExperience in setting up and drafting documents such as CEP, CER, PMCF, PSUR, etc.Knowledge of medical device regulations and standards (MDD / MDR, ISO 14971, ISO 13485)Experience drafting CERs in accordance with MEDDEV 2.7 / 1Experience with English-language literature searches, analysis, and synthesisExcellent professional English level, particularly in writingDynamic and proactive, you demonstrate strong interpersonal skills, autonomy, and rigor. You are curious, possess excellent writing skills, and have a strong sense of results and synthesis. You have a keen interest in medical devices, particularly in orthopedics and sports medicine. #J-18808-Ljbffr