Position Summary Implement RA operation strategy & plan in China to drive RA/CA excellence. Requirements1.      Education：Bachelor's degree or above in science and engineering through unified enrollment2.      Experience：Fresh graduates with outstanding performance are accepted, or those with 2-3 years of relevant ex-perience in QA, registration, compliance, and quality system in the medical device industry. Other skills1.      Computer skills (MS Office products, word processing, spreadsheets, etc.)2.      Good English reading and writing skills, capable of independently writing English emails, reviewing registration materials, and having basic oral communication skills, able to cooperate with interna-tional teams to complete simple meetings.3.      Good analyse and problem solving skill, be able to flexibly adjust strategies in the face of emergen-cies4.      High attention to detail and accuracy.5.      Good at internal and external communication6.      Can manage multiple concurrent tasks simultaneously.7.      Responsible, able to ensure tasks are completed with high quality and on time.8.      Respectful, stable.9.      International company experiences preferred10.    Good knowledge of medical device regulation preferred Job De****ionMain Tasks1.      Involved in establishing RA operation strategy & plan in China to drive RA/CA operation excellence, analyzing the gaps and needs together with global and local team for China RA/CA, optimizing local submission management process to enable effective registration and approval in China.2.      Involved in providing operational expertise to RA/CA teams for quality preparation and execution & approval.3.      Involved in setting up and maintaining regulatory processes (WI, SOPs) for China RA/CA compliance and in align-ment with global procedures whenever necessary.4.      Involved in driving and working with RA/CA to identify process improvement areas, develop and update local working processes.5.      Perform registration extension, communicate with Marketing and Global, secure no gap.6.      Maintain and update regulation, guidance database, industry data, etc., and deliver these documents to relevant departments or people as requested.7.      Collaborate with QA/logistics/Marketing team for Chinse label and IFU creation, review and release according to relevant processes and regulation to drive compliance, as well as IFU change notification.8.      Maintain the submission documents, certificate, PTR and test reports as well as UDI database according to re-quirements.9.      Provide expertise support to other departments, such as maintaining public share folder, label and IFU system, initial system, SAP system, etc.10.    Provide internal support, such as translation, payment, office supplies, CA, department seal, warehouse manage-ment as well as accomplishing the project assigned by operation leader or RACA head.

关于蔡司集团蔡司是全球光学和光电领域的技术先锋。在2023/24财年，蔡司集团的全年营收达近110亿欧元，覆盖工业质量与研究、医疗技术、光学消费品、半导体制造技术四大业务部门（数据截至2024年9月30日）。目前，集团收入的15%用于科学和研发。蔡司致力于为客户开发、生产和销售前沿创新的工业测量及质保解决方案，针对生物及材料科学领域的显微镜解决方案，以及应用于眼科及显微外科诊疗的医疗技术解决方案。蔡司也是全球光刻技术的行业标杆，其技术被芯片行业应用于半导体元件的制造。除此之外，蔡司品牌的眼镜镜片、相机镜头及望远镜等创新产品也适销全球。凭借着符合数字化、医疗保健及智能制造等未来发展趋势的产品组合，以及强大的品牌效应，蔡司正在塑造光学及其他相关领域的未来。蔡司在研发方面进行的可持续且大量的投入，为技术的不断发展、市场的持续扩张和公司的未来成功都奠定了坚实的基础。如今，蔡司集团在全球约50个国家拥有约46,500名员工。集团总部位于德国奥伯科亨。卡尔蔡司股份公司由卡尔蔡司基金会全资所有，后者在德国致力于积极促进科学发展。欢迎访问蔡司集团官方网站，了解更多信息。蔡司大中华区蔡司于1957年进入中国，目前在大中华区覆盖半导体制造技术、工业质量解决方案、研究显微镜解决方案、医疗技术、视力保健和消费者光学所有业务领域。2021年起，中国已成为蔡司在全球最大的单一市场，也是最具创新活力、增长最快的市场之一。在2023/24财年，蔡司大中华区营收达151亿元人民币，实现同比增长12%。蔡司在大中华区共有7,000余位员工，分布于各地的22个生产基地、销售与服务中心及研发中心，为本地客户提供强有力的支持，也为全球各相关业务提供生产保障。蔡司大中华区总部位于上海自由贸易试验区，设有销售服务总部、应用服务与培训中心、蔡司工业测量部生产工厂及蔡司集团在德国以外的首个企业级创新研发中心。蔡司上海总部及创新研发中心，协同苏州研发制造基地、广州知识城制造基地，逐步形成以高端光学镜片、医疗耗材为主的产业链闭环，全面支持中国本土研发与生产，携手本地合作伙伴共享高端产业可持续、高质量的发展机遇。更多信息，请参见蔡司中国官网。