職位描述
工作職責(zé)：
？ 負(fù)責(zé)所分配業(yè)務(wù)部產(chǎn)品全生命周期的法規(guī)相關(guān)事務(wù)，包括：
- 負(fù)責(zé)所分配業(yè)務(wù)部的新產(chǎn)品注冊(cè)申報(bào)工作、起草并整理相關(guān)申報(bào)資料，妥善保管注冊(cè)文件；
- 負(fù)責(zé)所分配業(yè)務(wù)部已有產(chǎn)品的延續(xù)注冊(cè)和變更注冊(cè)；
- 協(xié)助所分配業(yè)務(wù)部的產(chǎn)品檢測(cè),負(fù)責(zé)解決檢測(cè)過程中發(fā)生的問題；
- 保持同有關(guān)政府部門的聯(lián)系和溝通，跟蹤審批情況，協(xié)調(diào)相關(guān)工作；- 保持同所負(fù)責(zé)業(yè)務(wù)部產(chǎn)品線相對(duì)應(yīng)的境外合作伙伴的聯(lián)系和溝通，獲得相應(yīng)支持；- 負(fù)責(zé)所分配業(yè)務(wù)部產(chǎn)品批準(zhǔn)上市后的法規(guī)支持，解決后市場(chǎng)監(jiān)察相關(guān)問題。
？ 協(xié)助法規(guī)事務(wù)經(jīng)理制定所分配業(yè)務(wù)部的產(chǎn)品的年度預(yù)算計(jì)劃；
？ 協(xié)同市場(chǎng)部門制定所分配業(yè)務(wù)部的產(chǎn)品上市時(shí)間表；
？ 協(xié)助法規(guī)事務(wù)經(jīng)理做部門內(nèi)部的活動(dòng)計(jì)劃。
任職資格：
？ 熟悉醫(yī)療器械法規(guī)，一年以上醫(yī)療器械注冊(cè)經(jīng)驗(yàn)；
？ 一定的注冊(cè)項(xiàng)目管理能力,有效解決問題, 組織計(jì)劃能力；
？ 工作態(tài)度積極主動(dòng)，責(zé)任心強(qiáng)并具有良好的職業(yè)道德及敬業(yè)精神。
企業(yè)簡(jiǎn)介
Founded in 1897, BD is a world-wide leader of medical technology which manufactures and sells a broad range of supplies, devices and systems for use by healthcare professionals, medical research institutions, industry and the general public. We focus strategically on achieving growth in three worldwide business segments-BD Medical System (Core Medical, Consumer Healthcare, Pharmaceutical Systems, Ophthalmic Systems), BD Biosciences and BD Preanalytical Solutions. Our products are marketed in the United States and around the world. The latest Fortune magazine has listed BD in the top four “America’s Most Admired Companies” in the medical products, equipment category.
We believed in “Do what is right, Always seek to improve, Accept personal responsibility, Act in harmony.” Now we invite qualified, talented and self-motivated individual to develop with BD’s businesses in China.
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