职位描述

Responsibility You will be responsible to establish and maintain the good and closed relationship with SFDA testing centers. And successfully gaining product registration certificates per registration forecast plan. 和全国各 SFDA 检测中心保持良好关系，依据公司产品上市计划及时取得进口产品注册检测报告。- Establishing and maintaining the good and closed relationship with hospital IVD departments (clinical Lab, drug monitoring lab, GCP, etc…). And building up and representing Roche Diagnostics' good image, and gaining products clinical trial reports per action plan; 建立并保持与 IVD 临床机构（检验科，药剂科，药理基地 等）的良好关系，树立公司形象，并及时取得临床试验报告。- Monitoring and reporting on local regulation changes and its impact together to company. Assisting manager to handle daily work in Regulatory Dep; 将信息和政策导向及时通知公司。协助经理处理日常法规问题- Working with sales and marketing dep. to fulfill product registration plan. Achieving RD expectation on product registration; 与销售和市场部配合，完成注册计划。达到公司对产品注册的要求。- Establishing and maintaining the good relationship with key contacts. Recommending valuable suggestion to company; 建立并保持与政府部门及重点客户的良好关系，为公司提供有价值的意见。- As a member of RD, providing active and strong regulatory supports to internal dep. as needed; 作为团队的一分子,积极为各部门和内部员工提供及时和有力的政策法规的支持。- Initiatively dealing with daily works. Keeping records. Has clear filing and maintain of all documents. 积极主动处理其他日常法规问题。做好工作记录。文件分类归档，保留完好。 QualificationYou should hold:Bachelor degree or above, subject on Medical/bioengineering/ clinical Medicine or biochemistry; 大学本科以上学历，医学/ 生物工程/ 临床或生化专业.Familiar with medical device regulation; 熟悉医学法规。Fluent English in listening, speaking and writte and good skill on computer, MS-Office operation.英语流利，听说读写俱佳。熟练操作 MS-OFFICE 软件。You should have not less than 2 years about experience in medical regulatory affairs, focus on testing center and clinical trial. Understand IVD products' Standard like industry and national standards( YY and GB)有2 年以上医学法规领域的经验 ，有检测和临床经验优先。 了解 IVD 产品标准（行业和国家标准）。 职能类别： 医疗器械注册 其他

联系方式