職責(zé)描述：
Establish and improve the regulatory documentations.創(chuàng)建并優(yōu)化注冊(cè)文檔
Responsible for premarket products registration at CFDA, including document preparation, testing, submission and technical review, query answer and etc., to secure license in a good time manner. 產(chǎn)品注冊(cè)，包括文件準(zhǔn)備、檢測(cè)，遞交、技術(shù)審查、答疑等，優(yōu)質(zhì)按時(shí)完成注冊(cè)
Closely follow up ongoing projects with relate stakeholders. 緊密跟進(jìn)項(xiàng)目、聯(lián)系相關(guān)部門
Provide Regulatory supporting to BU in key countries of Asia, such as promotional material review, CFDA inspections. 為亞太關(guān)鍵國家提供及時(shí)的法規(guī)支持，例如宣傳資料的審核，藥監(jiān)檢查等
Assist manager to maintain and develop current regulatory knowledge of domestic and internationals, guidelines, and standards and apply appropriate implementation strategies.協(xié)助直線經(jīng)理維護(hù)法規(guī)知識(shí)、指導(dǎo)原則和標(biāo)準(zhǔn)，制定策略。
Requirements 要求:
- Bachelor’s degree, major in medical science or related field from an accredited college.醫(yī)學(xué)相關(guān)專業(yè)，本科以上學(xué)歷
- Previously experience on medical device company is preferred.醫(yī)藥行業(yè)相關(guān)經(jīng)歷優(yōu)先
- Ability to focus on details and accuracy 關(guān)注細(xì)節(jié)、準(zhǔn)確性
- Good written English skills.良好的書面英語能力
- Good communication skills, and teamwork ability. 善于溝通、團(tuán)隊(duì)合作。

Permobil集團(tuán)是全球領(lǐng)先的高端電動(dòng)輪椅、手動(dòng)輪椅(Tilite)、坐墊(Roho)等產(chǎn)品的生產(chǎn)和服務(wù)供應(yīng)商。集團(tuán)成立60余年來，一直專注于為客戶提供定制化的產(chǎn)品和服務(wù)，以最大限度的提高他們的生活品質(zhì)。集團(tuán)總部位于瑞典，目前在全球15個(gè)國家建立了分支機(jī)構(gòu)，并在70余國家和地區(qū)提供產(chǎn)品和服務(wù)。