职位薪资：10-15K·13薪
经验：3-5年
学历：本科
类型：全职
工作职责：
Responsibilities:
1. 负责准备，收集和整理需在中国销售之产品的法规注册所需的各类技术资料，并负责对这些资料的查证，验实递交相关政府部门。主要集中在昆山和松江工厂生产销售之产品，以及可能的进口注册产品。
Prepare and compile regulatory dossiers for submission to regulatory and government bodies in China. Focus on the products registration manufactured by KS and SJ plant , as well as those imported products if any.
2. 与PM协调，确保注册产品在注册开始,与生产厂协调， 确保注册产品在今后的生产过程中，更简便通过NMPA的审查的系列工作为产品的启动者， 与工厂和PM配合，协调产品在上市前的注册，试生产，生产的过程。 Communicate with PM to assure that the products to be registered in compliance and cooperate with factory to assure the necessary steps taken before the registration as well as supporting the NMPA audit.
3. 负责在中国销售之产品的法规注册申请，以及所有与法规注册相关的文件和证书。
Be responsible for all documentation and related certificates as pertains to regulatory applications and compliance in China which products needed to sales in Greater China market.
4. 为大中华区SBU的市场、销售各部门提供法律指导和支持服务。
Provide regulatory guidance or supporting service to marketing and sales department within greater China SBU.
5. 负责监督公司所有在中国市场已上市产品，使之符合相应的法规要求。如有必要，及时报告。
Be responsible for post-market surveillance and monitoring continuing compliance of all products already on the domestic China market, and Report in time if necessary.
6. 与国家各机关保持联系，了解、学习各类医疗设备法规最新要求，保证Amsino的产品及时注册和符合国家食品药品监督管理局的法规要求。
Interact with state agencies regulating various classes of medical devices, study regulatory requirements and ensure compliance regulations, and register Amsino products with the SFDA.
7. 为大中华区SBU的销售、市场人员开展产品注册所需的法规要求以及国家食品药品监督管理局之最新法规定的培训工作。
Engage in the training of sales and marketing people in Greater China SBU for the regulatory compliance requirements and updating regulations from NMPA.
8. 如需要，协助大中华区SBU的市场人员协调政府事务。
Cooperate with Greater China SBU to communicate with related government affairs if necessary。
任职资格：
Qualifications:
1.大学本科以上学历，医药类优先。
Bachelor degree or above; MD or Pharmaceutical is preferable
2. 3年以上的法规事务工作经验，有医疗产品知识者优先；
Above 3 years experiences in Regulatory Affairs, demonstrated knowledge of medical products preferred;
3. 较强的组织管理能力，良好的团队合作能力；
Strong organizational skills; cooperating and easygoing for teamwork;
4 . 极佳的口头和书面的沟通能力，英语流利。
Excellent communication skills (both verbal and written) ,proficient in English
