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Your mission and responsibilities: 1.Get the country approvals of China market, which includes creating a project plan, preparing the necessary documents with corresponding experts (e.g. product standard, user manuals etc. ), arranging type test and clinical evaluation, submitting application, and so on. 取得中國市場的國家準入，包括指定項目計劃，與相關專家共同準備相應的必要文件（例如，產品標準，用戶操作手冊），安排型式檢測，臨床評估，提交申請等等。 2.Monitoring the development and internal implement of domestic and international technical regulations and standards in order to effectively support our business interests 監(jiān)控本地及國際技術標準和法規(guī)的發(fā)展和內部實施情況，有效支持公司業(yè)務利益。 3.Identify and monitor the mandatory technical standards and regulations that our products need to be fulfill and keep them up to date, and follow up the implementation and compliance. 識別和監(jiān)控產品需要滿足的強制性技術標準及法規(guī)并維護更新，及后續(xù)的實施與跟進。 4.Maintenance of the license for production and operation in the scope of medical device regulations 醫(yī)療器械法規(guī)內生產/經(jīng)營許可證的維護 Your qualifications and experiences: 1. Professional NMPA regulations knowledges and NMPA registration 2 years’ experience/專業(yè)的中國醫(yī)療器械法規(guī)注冊知識和兩年以上的產品注冊經(jīng)驗 2.Perfect technical writer/優(yōu)秀的技術文檔編輯能力 3.Public relations and a project leadership skill is preferred/良好公共關系能力及項目管理技能優(yōu)先 4.medical device product knowledge/醫(yī)療器械產品知識 5.perfect English is preferred/流利的英文優(yōu)先 6.procedure