上海招聘

工作职责：

1. 负责进行体外诊断试剂、仪器等医疗器械产品的注册申报工作；

2. 负责安排产品的注册计划，跟踪注册进程，包括文件准备、试生产、产品检测、临床、注册申报等各阶段的实施工作；

3. 负责注册申报资料的编写、收集和整理、存档，包括产品综述、原料和工艺的选择、产品技术要求、注册检验、临床试验、申报表等；

4. 负责和药监管理部门、检测机构、临床机构、审评中心建立良好的合作关系，保持公司对外的良好沟通；

5. 负责与公司内部研发、生产、质量等环节进行良好的沟通，为各部门提供法规和技术咨询，组织法规培训，对实施过程作监督指导。

任职资格：

1.211/985硕士及以上学历，临床医学、检验学、生物医学工程、机械类等相关专业；

2.具备中文良好的沟通表达能力，英文良好的听说读写和翻译能力。

上海艾瑞德生物科技有限公司成立于2012年，位于上海市闵行区漕河泾高新技术园区，始终坚持“让品质诊断产品惠及每一个人”的使命，经过10年时间的发展，凭借服务至上，技术领先，功能优越，和国内外500余家医院建立合作关系，与哈佛大学、耶鲁大学、东京大学、上海交通大学、复旦大学、中科院等国内外***院校以及美国、德国、日本等行业领域内的龙头企业共创IVD精尖技术平台，现拥有国家知识产权70余项。

艾瑞德致力于胶体金、荧光免疫学等前沿生物领域研究，开发并成功上市超敏C-反应蛋白（hs-CRP）、降钙素原（PCT）、B型钠尿肽（BNP）、心肌三项等测定试剂盒及干式免疫分析仪、全自动样品处理系统等产品，形成了自有研、产、销体外诊断完整产业链。

艾瑞德秉承开放、透明、求真、简约的理念，荣获上海地区“非常雇主”、“专精特新”企业资质等荣誉；立足客户需求，提供品质一流的产品，致力成为全球体外诊断行业的卓越服务商。

Shanghai i-Reader Biotech Co., Ltd was founded in 2012, located in Caohejing Hi-Tech Park, Minhang district. “Contributing to human health” is always our first mission. And after ten years of development, with supreme service, leading technology and superior functions, we have established cooperative relationships with more than 500 hospitals at home and abroad, and have created IVD sophisticated technology platform with leading universities such as Shanghai Jiao Tong University, Fudan University, Chinese Academy of Sciences, and The University of Tokyo, as well as leading companies in the US, Germany, and Japan. Now we have more than 70 national intellectual property rights.

I-Reader is engaged in the research and development of frontier areas of biology such as colloidal gold and fluorescent immunology. We have formed a complete industrial chain of in-vitro diagnosis owning independent research, production and sales, with Brain natriuretic peptide (BNP), procalcitonin (PCT), hypersensitive C-reactive protein (hs-CRP) elisa kit, and the automatic dry-type immunity analyzer in the market and other products.

Adhering to the concept of openness, transparency, authenticity and simplicity, i-Reader has gained lots of honors like “China Best Employers” in Shanghai, “Specialized, Refined, Special and Innovative” enterprise qualifications, etc. Based on customer needs, we provide top-quality products and strive to become an excellent service provider in the global in-vitro diagnostic industry.