北京 [切换城市] 北京招聘北京质量管理/安全防护招聘北京质量管理/测试工程师(QA/QC工程师)招聘

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.


公司介绍

Intuitive Surgical is the global leader in the rapidly emerging field of robotic-assisted minimally invasive surgery with presence in more than 60 countries around the world.
  
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)