Job responsibilities 工作職責 1.To be responsible for the registration and declaration of Medicine products , to independently compile medicine registration documents, to examine, organize and submit registration materials.負責國外藥品產品的注冊申報，獨立編寫藥品注冊文件，審核，整理及遞交注冊材料。 2.To master and follow up the changes of medicine registration regulations and quality regulations, analyze, summarize, organize and report to the quality manager in time to assist the implementation of the new regulations in the factory.掌握和跟蹤國外藥品注冊法規和質量法規的變化，及時分析，歸納，整理，并匯報質量經理，協助新法規工廠內的落實。 3.Responsible for handling matters encountered in the registration and quality certification of related products such as the competent government or institutions.負責處理各主管政府或者機構等相關產品注冊，質量認證中遇到的事務。 4.Responsible for the relevant inspection, testing and follow-up progress during the medicine registration process, such as type test, biocompatibility test, verification test, etc.負責藥品注冊過程中的相關檢驗，測試并跟進進度，例如型式實驗，生物相容性測試，包裝運輸驗證測試等。 5.Responsible for communicating with other relevant departments during registration process, taking the lead in solving some problems and assigning project implementation.負責注冊過程中與其他相關部門的溝通，牽頭解決一些問題并分派項目實施。 6.Assist the quality manager to build and improve the internal quality management system and participate in the internal and external audit of the quality management system.協助質量經理進行公司內部質量管理體系的建設和完善，參與質量管理體系的內審和外審工作。 7.Complete other related work assigned by company leader.完成公司領導分配的其他相關工作。 Job requirements 崗位要求 1.Bachelor degree or above in medicine, biology, materials, medical devices, etc., at least one year's experience in medicine registration.醫學類，生物類，材料類，醫療器械類等相關專業本科及以上學歷，至少一年醫藥類注冊工作經驗。 2.To be familiar with the domestic and international medicine and other related laws and regulations and registration declaration, familiar with CE/FDA registration and other guiding principles ,510 K registration experience is preferred.熟悉國際醫藥等相關法律法規及注冊申報事宜，熟悉CE/FDA 注冊等各項指導原則，有510K 注冊經驗尤佳。