職位描述
職責描述：
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. 緊密跟進項目、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)理維護法規(guī)知識、指導原則和標準，制定策略。
Requirements 要求:
- Bachelor’s degree, major in medical science or related field from an accredited college.醫(yī)學相關(guān)專業(yè)，本科以上學歷
- 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)注細節(jié)、準確性
- Good written English skills.良好的書面英語能力
- Good communication skills, and teamwork ability. 善于溝通、團隊合作。
企業(yè)介紹
Permobil集團是全球領(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)和服務供應商。集團成立60余年來，一直專注于為客戶提供定制化的產(chǎn)品和服務，以最大限度的提高他們的生活品質(zhì)。集團總部位于瑞典，目前在全球15個國家建立了分支機構(gòu)，并在70余國家和地區(qū)提供產(chǎn)品和服務。
