主要工作职责（基本概况，主要功能，权限等）

This role will handle various cases from local administration for market regulation including investigation association, complaint. 该职位只要负责来自地方市场监督管理局各类案件，如协查，投诉等。

This role will also support related post market collaboration project and industry forum with health authorities, association, universities and colleges. 负责支持与卫生主管当局、协会、高校与内部之间上市后的相关项目合作，论坛等。

This role will handle product sampling from post market surveillance by local administration for market regulation and NMPA. 处理上市后产品抽样结果，对异常跟踪协调。

Collect regulations on medical device industry at National & province level and lead internal analysis.法规收集，组织内部法规分析。

This role will lead department culture establishment activities, including but not limit department, cross-functions, region and global. 负责部门文化建设活动，包括不限于部门内部，跨部门，跨区域及全球的相关活动。

This person is expected to follow all company compliance requirements including but not limit as safety policies & other safety precautions within work area, HCC, finance compliance, plan and manage department budget。负责跟踪公司各项合规政策要求包括不限于EHS, HCC, FIN等合规工作， 计划及管理部门预算。

基本任职资格（包括教育背景和/或知识和/或培训和/或相关工作经验）

• At least 5 years’ experience in Quality, Compliance, Regulatory, Operations, Engineering, NPD , and/or Manufacturing of medical device or pharmaceutical industry, bachelor degree or above, preferred background like, Post market surveillance, registration Public health, health insurance, government affairs, etc. 医药领域质量、注册法规，运营、生产相关岗位5年及以上工作经验，大学及以上学历（上市后监管、公共卫生、医保、管理、生物医药等背景优先考虑）

• Have insight on policy of medical device industry and be ability to analysis of interpretation for current regulations & policy.对中国的医药行业及医改政策环境有深入的理解，有较强的政策分析、报告撰写以及解读能力.

• Experienced on post market surveillance management, like project, policy & customer management.在产品上市后监管方面有较丰富的项目、政策和客户管理经验。

• Good at team work and cross function communication善于与他人合作，具有较强的团队协作精神。

• Can be adapt to the changing environment and work under challenge.能适应复杂或具有挑战的环境，具有较强的抗压能力和应变能力；

• Will to learning , be positive attitude and considerate工作细致认真，富有责任心，善于学习，心态积极向上。

• Strong coordination and communication skill. 较好的组织协调及沟通能力。

• The ability to lead a cross-functional team is required and experience leading cross-company and/or cross-region teams is preferred. 有领导到跨部门，跨国家的项目优先。

• Demonstrated understanding of an end to end Quality.理解端到端质量管理。

• Advanced proficiency with verbal presentation both in Chinese English is required. 中英文口表达能力。

• Technical writing skills and experience are preferred. Proficiency with MS Office.较好文件写作能力，熟练操作MS Office

上班地址：桂箐路65号新研大厦