岗位职责
KEY RESPONSIBILITIES 工作职责
1.Lead thepreparation for CE certificate changed from MDD to MDR for CE class IIa activemedical devices.
主导CE 有源IIa类产品MDD证书转版为MDR证书的准备工作。
2. Evaluate the gapof current technical files and quality management system documents accordingthe MDR requirement and make the project plan and lead the modification.
根据新法规MDR要求，评估目前产品技术文档和质量体系文件的差距，制定项目计划并主持相关修改工作。
3.The leader forthis MDD-MDR change project, work closely with the consultant, notify body,customers and relative departments and ensure to get the MDR certificate asscheduled.
作为MDD-MDR换版项目负责人，密切与顾问、认证机构、客户及公司各部门沟通，确保按计划完成换证工作。
4.Other tasksassigned by management.
上级领导分配的其他任务。
QUALIFICAITON任职要求：
1.College degreeor above in Science and engineering, at least 3 year related working experiencein CE active medical devices registration.
大专 或以上学历，理工科专业， 3 年或以上CE有源医疗器械注册工作经验；
2.Projectexperience in handling CE medical devices registration independently andfamiliar with ISO 13485 and MDD。
有独立负责CE产品注册项目的经验，熟悉ISO13485和MDD法规。
3. Language skillsFluent in mandarin and English
语言能力：流利的普通话和英语
4.Excellentcommunication skill and team work spirit
的的沟通能力及团队精神
5.Skilledoperation of Office and relative software
办公软件和辅助软件熟练
6.Certifiedauditor ISO13485 is prefer
有ISO13485内审员资格证书尤佳
7. Have knowledgeof MDR requirements is prefer
了解MDR法规要求的优先
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