Responsibilities：
1.Develop site regulatory and clinical affairs strategy, and subsequent implementation plan. Calibrate the regulatory and clinical affairs practice in the region, optimize the existing system and continuous improvement.
2.Establish operating budgets, monitor the cost, effectiveness, and reliability of regulatory and clinical affairs activities to optimize resources, priorities spending, and ensure that targets and standards are met.
3.Set up registration plan for the responsible project, take leader for preparation and submission of applications, renewals and variations to the relevant authorities, in a timely and accurate manner. Follow up with regulatory authorities on submissions and regulatory issues.
4.Participate in the compliance validation before the mass production for the registered product, including the product pattern, package size, package design etc.
5.Provide project / study management for clinical trials consistent with applicable regulations, guidelines and policies.
6.Responsible for Medical Device Manufacturing Enterprise License application and annual check.
7.Providing appropriate regulatory input to project team to ensure planned product development activities comply with the guidelines, and provide a critical analysis of the risks and issues in case.
8.Direct negotiations and liaisons with third party companies, and other departments of the company concerning submission applications.
9.Closely monitor the latest regulations, guidelines and legislation, uate the impact to company, and organize the training and plan in case.
10.Develop and improve good relationship with the authorities, clinical center etc., and promote company image.
11.Responsible for training and career development of the team through setting ives and performance review processes.

Requirements：
1. Advanced level of English.
2 .At least 5 years of experience in medical device or pharmaceutical industry, and more than 3 years medical device or pharmaceutical international company regulatory and clinical affairs management experiences.
Excellent knowledge and competency in medical device or drug registration experience.
Familiar with medical device or drug regulations and guidelines.
Good relationship with SFDA and affiliates.
Good communication skill, creative thinking, with teamwork spirit.
4.Education：
Bachelor degree or above.

艾博生物医药（杭州）有限公司是一家成立于2003年的高科技生物技术外资企业，坐落于国家级开发区——杭州经济技术开发区（下沙）医药园区内。公司占地面积近百亩，建筑面积达3万平方米，由国外著名设计单位进行总体设计，风格独特，环境优雅，为员工提供了舒适的工作环境，为花园式工厂的典范。
公司主要从事研究、开发、生产体外诊断试剂。公司注册资本2200万美元。公司产品已获美国FDA注册和欧洲CE注册，主导产品为快速诊断产品，包括妇女健康、传染病、毒品、肿瘤、心血管等五大系列，畅销全球100多个国家和地区，在北美、欧洲、以色列、澳大利亚、日本、新西兰等国际市场上占有较高的份额，并且从2011年开始，正式打开国内市场。

公司拥有强大的科研开发和技术创新能力，在胶体金、乳胶等标记技术，单克隆抗体、多克隆抗体、基因重组抗原、合成抗原等生物原料技术以及免疫层析技术等前沿生物领域的研究方面处于国内领先水平。公司已通过了欧洲TUV的ISO13485：2003质量管理体系认证并被国家发展和改革委员会认定为国家高技术产业化示范工程项目。迄今，已获得国家高新技术企业、浙江省企业技术中心、浙江省专利示范企业、杭州市服务外包出口成长前十名等多项荣誉称号。