工作职责 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.负责国外药品产品的注册申报，独立编写药品注册文件，审核，整理及递交注册材料。 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.掌握和跟踪国外药品注册法规和质量法规的变化，及时分析，归纳，整理，并汇报质量经理，协助新法规工厂内的落实。 3.Responsible for handling matters encountered in the registration and quality certification of related products such as the competent government or institutions.负责处理各主管政府或者机构等相关产品注册，质量认证中遇到的事务。 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.负责药品注册过程中的相关检验，测试并跟进进度，例如型式实验，生物相容性测试，包装运输验证测试等。 5.Responsible for communicating with other relevant departments during registration process, taking the lead in solving some problems and assigning project implementation.负责注册过程中与其他相关部门的沟通，牵头解决一些问题并分派项目实施。 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.协助质量经理进行公司内部质量管理体系的建设和完善，参与质量管理体系的内审和外审工作。 7.Complete other related work assigned by company leader.完成公司领导分配的其他相关工作。 Job requirements 岗位要求 1.Bachelor degree or above in medicine, biology, materials, medical devices, etc., at least one year's experience in medicine registration.医学类，生物类，材料类，医疗器械类等相关专业本科及以上学历，至少一年医药类注册工作经验。 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.熟悉国际医药等相关法律法规及注册申报事宜，熟悉CE/FDA 注册等各项指导原则，有510K 注册经验尤佳。