Label Compliance Engineer
直观复星医疗器械技术(上海)有限公司
- 公司规模:150-500人
- 公司性质:合资
- 公司行业:医疗设备/器械
职位信息
- 发布日期:2019-08-11
- 工作地点:上海-浦东新区
- 招聘人数:1人
- 工作经验:无工作经验
- 学历要求:招1人
- 语言要求:不限
- 职位月薪:1-1.5万/月
- 职位类别:质量管理/测试工程师(QA/QC工程师)
职位描述
Primary Function of Position:
Provides subject matter expertise to all product labeling activites, to ensure the product label meet with NMPA regulation and China importation requirements.
Roles and Responsibilities:
This position has responsibility and authority for:
? Interpreate medical device labeling regulation.
? Provide input for product label design and manual draft, and review them as SME.
? Responsible to communicate and response any questions with Customs, CIQ, NMPA and Customer.
? Implement labeling procedure to ensure final product shipment to China.
? Monitor the labeling activities and implementation internal and external (3rd party agent).
? Handle post market recall/report activities
Skill/Job Requirements:
Competency Requirements: In order to adequately perform the responsibilities of this position the individual must possess:
? Bachelor’s degree
? 3~5 years experience in the relevant role of medical device product
? Knowledge of China medical device regulation, such like registration, quality. QA or RA work experience will be preferred
? Experience to handle importation and communication with Customs and CIQ
? Be proficient in written and spoken Enligsh.
职能类别: 质量管理/测试工程师(QA/QC工程师)
公司介绍
Intuitive Surgical-Fosun Medical Technology (Shanghai) Co., Ltd. is the Joint Venture between Intuitive Surgical and Fosun Pharma- a subsidiary of Fosun International, a leading Pharma and Medical Device Company in China.
The intent of the Company is to research, develop and manufacture innovative, robotic-assisted catheter-based Medical Devices.
联系方式
- 公司地址:浦东新区 (邮编:201200)