上海 [切换城市] 上海招聘上海生物/制药/医疗器械招聘上海医疗器械注册招聘

SSME DH Sr Regulatory Affairs Officer

上海西门子医疗器械有限公司

  • 公司规模:1000-5000人
  • 公司性质:外资(欧美)
  • 公司行业:医疗设备/器械

职位信息

  • 发布日期:2019-11-06
  • 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
  • 职位类别:医疗器械注册

职位描述

Position Summary:

Ensure SSME products and process complying with relevant international and notional standards and regulations. Take responsible fro product registration. 


Responsibility:

1.       Ensure product and process compliance with relevant and international laws and regulations. 
2.       Establish and maintain product market clearance and other compulsory certification process. 
3.       Responsible for market clearance and other compulsory certificate for new product. 
4.       Communicate with government office and Siemens internal relevant organization to set up a network to improve market clearance process. 
5.       Cooperate and coordinate closely with new project team to ensure market clearance and other compulsory certificate process smoothly and efficiently. 
6.       Well communicate with business unite about the progress and status. 
7.       Responsible for coordination of factory inspection from third party. 
8.       Regulator knowledge sharing in team.


Experience:

At least 3 years experience in Regulatory affairs.


Education:

University and above.


职能类别:医疗器械注册

公司介绍

在西门子医疗,我们的目标是通过全面实现数字化医疗,助力医疗服务提供者在各自领域推进精准医疗、转化诊疗模式、改善患者体验,以全方位助力其提升价值。每一天,全球有五百万名患者在影像诊断、临床诊疗、实验室诊断、分子医学以及数字化医疗和企业服务方面受益于我们的创新技术和服务。拥有超过170年历史,在全球范围内持有18,000个专利,西门子医疗是领先的医疗技术公司。我们在全球超过70个国家约50,000名员工将继续创新,塑造医疗行业的未来。
At Siemens Healthineers, our purpose is to enable healthcare providers to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, and improving patient experience, all enabled by digitalizing healthcare.
An estimated five million patients globally everyday benefit from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.
We are a leading medical technology company with over 170 years of experience and 18,000 patents globally. With about 50,000 dedicated colleagues in over 70 countries, we will continue to innovate and shape the future of healthcare.

联系方式

  • 公司地址:周祝公路278号