職位描述
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職位職能:
??醫(yī)療器械注冊??生物工程/生物制藥
職位描述:
JOB TITLE: Regulatory Affairs Specialist--Beijing
PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB
1. Responsible for documentation preparation of product registration; Ensure the document compliant with relevant regulation requirements in China
2. Responsible for coordination of each function’s activities to finish product registration according to China regulation
3. Responsible for liaison with the Chinese regulatory authorities
4. Response for collects related update regulation information
5. Implement the registration Clinical Trial to ensure the correct direction via the selection of predicate in China
KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB
Experience & Personality:
1. Minimum 3 years of medical device product registration experience, IVD is preferred
2. Familiar with BMC portfolio, and know the resource both technical and guanxi.
3. Good interpersonal and communication skills, team player and taking ownership
4. Able to work under pressure and fast response
Education & Knowledge:
1. Bachelor’s Degree or above in clinical medicine, biology & pharmacy or related major.
2. Basic English skill of reading and writing
職位名稱：注冊事務(wù)專家
1．首要工作任務(wù)和總體工作目標(biāo)
根據(jù)技術(shù)資料起草產(chǎn)品注冊標(biāo)準(zhǔn)，確保其符合中國SFDA的相關(guān)法律規(guī)定。
1. 協(xié)調(diào)相關(guān)部門，按照計劃完成產(chǎn)品的注冊；
2. 負(fù)責(zé)和藥監(jiān)局官員保持良好的溝通和聯(lián)絡(luò)；
3. 負(fù)責(zé)收集相關(guān)規(guī)章制度的實時信息。
4. 負(fù)責(zé)產(chǎn)品注冊所需的相關(guān)臨床試驗注工作
5. 跟蹤醫(yī)療器械法規(guī)變化情況；根據(jù)法規(guī)向管理層提供相應(yīng)產(chǎn)品的注冊建議；
6. 跟蹤產(chǎn)品注冊和審評進(jìn)程；
學(xué)歷和經(jīng)驗要求
工作經(jīng)驗和個人能力：
1. 從事醫(yī)療器械產(chǎn)品注冊工作3年以上的工作經(jīng)驗，所涉領(lǐng)域為體外診斷器材者優(yōu)先。
2. 熟悉BMC portfolio, 對注冊相關(guān)的技術(shù)和人脈關(guān)系都有所掌握
3. 良好的人際關(guān)系，溝通能力，良好團(tuán)隊協(xié)作和高度的責(zé)任感
4. 能夠承受工作壓力并作出快速反應(yīng)。
教育和知識要求：
1. 擁有臨床醫(yī)學(xué)、生物學(xué)、藥學(xué)或相關(guān)專業(yè)的本科及以上學(xué)歷。
2. 良好的英語讀寫能力。
