職責(zé)描述：
Establish and improve the regulatory documentations.創(chuàng)建并優(yōu)化注冊文檔
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，包括文件準(zhǔn)備、檢測，遞交、技術(shù)審查、答疑等，優(yōu)質(zhì)按時完成注冊
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、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)先的高端電動輪椅、手動輪椅(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)。