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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 監控本地及國際技術標準和法規的發展和內部實施情況，有效支持公司業務利益。 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. 識別和監控產品需要滿足的強制性技術標準及法規并維護更新，及后續的實施與跟進。 4.Maintenance of the license for production and operation in the scope of medical device regulations 醫療器械法規內生產/經營許可證的維護 Your qualifications and experiences: 1. Professional NMPA regulations knowledges and NMPA registration 2 years’ experience/專業的中國醫療器械法規注冊知識和兩年以上的產品注冊經驗 2.Perfect technical writer/優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先 4.medical device product knowledge/醫療器械產品知識 5.perfect English is preferred/流利的英文優先 6.procedure