崗位職責
KEY RESPONSIBILITIES 工作職責
1.Lead thepreparation for CE certificate changed from MDD to MDR for CE class IIa activemedical devices.
主導CE 有源IIa類產品MDD證書轉版為MDR證書的準備工作。
2. Evaluate the gapof current technical files and quality management system documents accordingthe MDR requirement and make the project plan and lead the modification.
根據新法規MDR要求，評估目前產品技術文檔和質量體系文件的差距，制定項目計劃并主持相關修改工作。
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.
作為MDD-MDR換版項目負責人，密切與顧問、認證機構、客戶及公司各部門溝通，確保按計劃完成換證工作。
4.Other tasksassigned by management.
上級領導分配的其他任務。
QUALIFICAITON任職要求：
1.College degreeor above in Science and engineering, at least 3 year related working experiencein CE active medical devices registration.
大專 或以上學歷，理工科專業， 3 年或以上CE有源醫療器械注冊工作經驗；
2.Projectexperience in handling CE medical devices registration independently andfamiliar with ISO 13485 and MDD。
有獨立負責CE產品注冊項目的經驗，熟悉ISO13485和MDD法規。
3. Language skillsFluent in mandarin and English
語言能力：流利的普通話和英語
4.Excellentcommunication skill and team work spirit
的的溝通能力及團隊精神
5.Skilledoperation of Office and relative software
辦公軟件和輔助軟件熟練
6.Certifiedauditor ISO13485 is prefer
有ISO13485內審員資格證書尤佳
7. Have knowledgeof MDR requirements is prefer
了解MDR法規要求的優先
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