北京 [切换城市] 北京招聘北京生物/制药/医疗器械招聘北京医疗器械注册招聘

Regulatory Affairs Specialist

快臻贸易(上海)有限公司

  • 公司规模:50-150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:2018-03-23
  • 工作地点:北京
  • 工作经验:3-4年经验
  • 学历要求:本科
  • 语言要求:英语熟练
  • 职位月薪:1-1.5万/月
  • 职位类别:医疗器械注册  政府事务管理

职位描述

Responsibilites:

Monitor the whole registration process to gain product registration certificates to ensure fulfill product registration plan.

Ensure compliance with China regulatory requirements.

Establish and maintain good relationship with key contacts.

Provide active and strong regulatory supports to internal dep. as needed.

Keep good and clear documentations and filings.


Requirements:

Bachelor degree or above, major in Medical or Biochemistry related.

Around 3 ~ 5 years working experiences in medical device regulatory affairs, understand IVD products' standards.

Familiar with medical device regulations.

Excellent verbal and written communication in English.

职能类别: 医疗器械注册 政府事务管理

公司介绍

Quidel Corporation (Nasdaq: QDEL) is a California-based leading diagnostic healthcare manufacturer serving to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system.

Quidel commenced operations in 1979 and launched its first products in 1984. Since that time, Quidel has expanded its product base through internal development and acquisition with a focus on increasing its research and development efforts to accelerate the rate of new product introductions. Our core competencies and capabilities include immunoassay development, automated manufacturing, monoclonal antibody characterization and development, and molecular assay development. Our current products fall generally into these categories: (1) lateral flow, where we are market leaders in infectious disease and reproductive health; (2) direct fluorescent antibodies (DFA), with expertise in infectious disease and virology; (3) micro-titer production, with a focus on bone and complement pathway markets; (4) fluorescent immunoassay products (Sofia); and (5) molecular diagnostic products including the world’s first FDA-cleared handheld molecular device, AmpliVue. Additional molecular and Sofia tests are currently in development or in clinical trials as part of a robust product pipeline.

Whether at our headquarters in San Diego, California, at our research and manufacturing operations in Ohio, Massachusetts, or in Germany, or through our Commercial organization around the world, Quidel is delivering a continuum of diagnostic solutions from advanced lateral-flow and direct fluorescent antibody to molecular diagnostic tests that further improve the quality of healthcare.

联系方式

  • 公司地址:北京