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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(chǎng)的國家準(zhǔn)入，包括指定項(xiàng)目計(jì)劃，與相關(guān)專家共同準(zhǔn)備相應(yīng)的必要文件（例如，產(chǎn)品標(biāo)準(zhǔn)，用戶操作手冊(cè)），安排型式檢測(cè)，臨床評(píng)估，提交申請(qǐng)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(shù)標(biāo)準(zhǔn)和法規(guī)的發(fā)展和內(nèi)部實(shí)施情況，有效支持公司業(yè)務(wù)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(shí)別和監(jiān)控產(chǎn)品需要滿足的強(qiáng)制性技術(shù)標(biāo)準(zhǔn)及法規(guī)并維護(hù)更新，及后續(xù)的實(shí)施與跟進(jìn)。 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(nèi)生產(chǎn)/經(jīng)營許可證的維護(hù) 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(cè)知識(shí)和兩年以上的產(chǎn)品注冊(cè)經(jīng)驗(yàn) 2.Perfect technical writer/優(yōu)秀的技術(shù)文檔編輯能力 3.Public relations and a project leadership skill is preferred/良好公共關(guān)系能力及項(xiàng)目管理技能優(yōu)先 4.medical device product knowledge/醫(yī)療器械產(chǎn)品知識(shí) 5.perfect English is preferred/流利的英文優(yōu)先 6.procedure