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Post Marketing Surveillance 醫療器械質量監管員 1-1.5萬/月/月

邁柯唯（上海）醫療設備有限公司

上海

本科
02-22 發布

職位信息

職位名稱： Post Marketing Surveillance 醫療器械質量監管員

類別名稱：

職位描述：

職位描述：Main responsibilities:.To support establish & maintenance PMS related SOP, WI and/or system to be consistence with latest regulation and QMS request..To responsible for monitoring and follow up of complaint case from China market。.To maintain the recall system in China Sales and Service Unit, including but not limited to report liability to local FDA authority, follow up of recall/field action status, communication with factories and the closure of recall case..To handle the adverse event report system,report the domestic adverse event to local authority; review and check global doubt AE report against local regulation, and responsible for the document submission and final reporting..Take the responsibilities of PMS related training to all employees..Be coordinator of after-market related quality issue..Other duties assigned by department head.Quality System Duties and Responsibilities:.Build Quality into all aspects of their work by maintaining compliance to all quality requirementsRequired Knowledge/Skills/Experience:.Bachelor’s degree on subjects of Medical device/life science/chemistry or other relevant science.Minimum 5 years related experience in medical device/pharmacy related quality management, manufacturing or auditor role..Previous background and experience in quality management or auditing activities.Strong knowledge and experience in ISO13485, FDA QSR 820, CFDA GxP related regulations.

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