Johnson & Johnson Careers

Quality Manager

Shanghai, Shanghai
Compliance


Job Description

Requisition ID: 1805644225W

Principal Duties and Responsibilities (General Summary ,essential functions and authorities, etc.) 

  • 主要工作职责(基本概况,主要功能,权限等)

    Fully understand the regulations on  medical device industry at National & province level, familiar with the process on postmarket survilance of ShanghaiFDA, can have influence on health authority through project, industry forumn, etc.全面掌握国家及各省市(特别是上海市)医疗器械上市后监管的政策法规,了解上海市局及各区市场监督局(浦东、徐汇)的联动政策,加强对市及区局医疗器械监管政策和法规的影响力。

    As per global & JJMS quality & compliance core objective,  have good engagement with Shanghai FDA , reduce impact of regulatory agency enforcement actions of company.了解和掌握上海市食品药品监督管理局和各区市场监督局的业务流程及动向,根据公司的战略目标做好后市场监管政策影响与落地,

    Strength on engagement with RA/GA department , identify and monitor potential complaince risk during postmarket survillance, like investigation from Market Supervision Administration, porduct sampling etc.加强与RA/GA等部门的沟通,及时识别和监控和公司相关的后市场监管的调查,例如市场监督局协查,产品抽样结果异常跟踪协调。


    Other responsibilities defined in written procedures.

    流程中规定的其它职责。

    Lead team to support government / industry associate related projects.组织领导和参与政府部门或行业协会的相关项目。


Qualifications

Basic Requirement, including Education and/or Knowledge and/or Training and/or key Relevant Experience required.

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 experence on medical device or pharmaceutical  industry , Bachelor degree or above, prefered background like, Public health, health insurance, government affairs, registration etc 医药领域政府事务、注册法规相关岗位5年及以上工作经验,大学及以上学历(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 ablity to analysis of interpretation for cureent 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 survillance 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 enviorment 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

§  Good English at read, written and oral.具备日常英语沟通能力(包括英文书面邮件和口语).

§  Domestic travel 1-2 /month 能接受出差 ,每月1-2



Primary Location
China-Shanghai-Shanghai
Organization
Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function
Compliance
Requisition ID
1805644225W