職位描述
職位描述：
PART I - POSITION SUMMARY 職位概要
Mainly engaged in registration for imported medical devices (including registration product standards, product inspection, register data preparation and filing), to make sure the progress of application.
主要從事進口醫療器械產品注冊的相關工作（涉及注冊產品標準、產品檢測、產品注冊資料的準備及整理），確保產品申報的進度。
PART II - PRINCIPAL RESPONSIBILITIES 主要職責
1. With manager or other people’s help, be responsible for the local registration of medical device products, to ensure registration is processed as plan, including:
在經理或其他人的幫助下，負責公司醫療器械產品在國內的注冊，確保產品的注冊進程按照計劃進行, 包括：
（1） Coordinate with Marketing, Sales and Global RA, to work out registration plan.
與市場部，銷售部，國際注冊部進行協調，制定注冊計劃
（2）According to the relevant regulations and standard requirements, draft the product technical requirements（depends on product), follow up product test. Keep in touch with the test institutions closely with a good relationship. Ensure test can be proceeded smoothly.
按照相關法律法規及標準的要求，起草產品技術要求(根據產品)，跟進產品檢測；與檢驗、測試機構保持密切聯系，建立良好關系，確保注冊檢驗的順利進行
（3）Communication with CFDA, to ensure submission, technical review and administrative approval to proceed smoothly in each application. Tracking product registration process to make sure the certification getting on time.
與國家藥監局等部門聯系溝通，確保各個注冊申請的報送、技術審評和審批的順利進行，實時跟蹤產品注冊進程，確保按時獲證
（4）To make necessary change, correction, IFU-Updating after getting the registration certificate.
取得注冊證書后,如需要,根據實際情況,進行注冊證書的變更、糾錯、說明書備案的工作
2. Study and understand local/international regulation, provide basic suggestion on registration or certification.
負責研究和了解國內國際的法律法規，為產品注冊或認證提供基本的咨詢建議
3. Maintain registration documents in order, file the product data.
有序管理產品的注冊資料文檔，負責產品的資料歸檔
4. To make the Chinese label and IFU according to CFDA’s requirements with manager or other people’s guide
在經理或其他人的指導下，根據CFDA的要求，制作產品的中文標簽和說明書
5. Provide related document to Commercial, Sales department.
提供公司商務、銷售部門招投標需要的有關法規文件。
PART III – QUALIFICATIONS 任職要求
EDUCATION 教育程度
Bachelor degree or above, major in Medical, Medical device, Biomedical Engineering, Electro-mechanics, Materials is preferred
大學本科及以上學歷，醫學，醫療器械、生物醫學工程、機電、材料等專業優先；
EXPERIENCE 工作經驗
1. At least 2 years experience in registration.
至少有2年產品注冊經驗。
2. Familiar with local medical device registration process, regulations and standards.
熟悉國內醫療器械產品注冊流程、行業法規規定及標準
3. Proficient in the use of MS Office suite.
能夠熟練操作常用辦公軟件。
OTHER QUALIFICATIONS (Physical, Visual etc.) 其他要求
1. common communication in Chinese and English
有通常水平的中英文溝通能力
2. Carefulness, preciseness, initiative and strong rationality, strong sense of responsibility and team work
工作作風細致、嚴謹、主動、條理性強，有高度的責任感和良好的團隊合作精神
