職位描述:崗位職責:1、負責公司醫療器械產品510K&CE注冊;2、按照相關法律法規及標準的要求,起草產品標準,跟進產品檢測,注冊檢驗,臨床試驗等;3、編寫、管理公司產品的技術文檔,提早開展注冊證到期的后續工作;4、與國家藥監局等部門聯系溝通,確保各個注冊申請的報送、審評和審批的順利進行,實時跟蹤產品注冊進程,確保按時獲證;5、與檢驗、測試、認證機構保持密切聯系,建立良好關系,確保各個產品的注冊檢驗和質量標準復核的順利進行;6、了解并研究國內國際新產品認證注冊的法律法規,翻譯相關產品技術資料,為新產品注冊或認證策略提供咨詢建議;7、在上級主管的指導下獨立開展工作,輔助并完成其他工作事項。任職要求:1、熟悉醫療器械注冊流程,完成產品注冊標準的編寫、注冊文件準備、聯系產品檢測等事務;有2年以上醫療器械產品注冊工作經驗,并成功注冊產品;2、熟悉國家有關醫療器械的各項法律、法規及國家和行業標準;3、具有良好的溝通能力與協調能力;4、能熟練應用電腦軟件,進行辦公自動化操作;5、工作細致、嚴謹、主動、條理性強,有高度的責任感和良好的團隊合作精神;Job Description:1.Responsible Registration Associate develop and implement international registration plan-510K&CE;2.Draft product standard, testing, registration and clinical trials3.Prepare and manage technical documentation, early follow-up jobs of certificate of registration expires4.Keep good relations with CFDA, make sure each submission, review and approval going smoothly; real-time tracking of registration process to ensure to meeting the deadline5.Well communicate with test centers to ensure the registration inspection and quality standard check smooth6.Understand and study new registration and regulation laws domestically and internationally, translate relative technique documents, and consult for new product registration plan or strategy7.Work independently for other jobsRequirements:1.Familiar with medical device registration process, complete product registration standards, registration documents preparation, contact product testing and other services; more than 2 years working experience in medical device registration, and successfully registered products2.Familiar with the national laws, regulations and national and industry standards of medical devices;3.Good communication and coordination skills;4.Meticulous, rigorous, initiative, strong sense of responsibility and good team work spirit;