職位描述
職責描述:
Establish and improve the regulatory documentations.創建并優化注冊文檔
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. 產品注冊,包括文件準備、檢測,遞交、技術審查、答疑等,優質按時完成注冊
Closely follow up ongoing projects with relate stakeholders. 緊密跟進項目、聯系相關部門
Provide Regulatory supporting to BU in key countries of Asia, such as promotional material review, CFDA inspections. 為亞太關鍵國家提供及時的法規支持,例如宣傳資料的審核,藥監檢查等
Assist manager to maintain and develop current regulatory knowledge of domestic and internationals, guidelines, and standards and apply appropriate implementation strategies.協助直線經理維護法規知識、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.醫學相關專業,本科以上學歷
- Previously experience on medical device company is preferred.醫藥行業相關經歷優先
- Ability to focus on details and accuracy 關注細節、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。
企業介紹
Permobil集團是全球領先的高端電動輪椅、手動輪椅(Tilite)、坐墊(Roho)等產品的生產和服務供應商。集團成立60余年來,一直專注于為客戶提供定制化的產品和服務,以最大限度的提高他們的生活品質。集團總部位于瑞典,目前在全球15個國家建立了分支機構,并在70余國家和地區提供產品和服務。