CF - Associate RA Manager, IOL (职位编号：39849435)
卡尔蔡司（上海）管理有限公司
- 公司规模：1000-5000人
- 公司性质：外资（欧美）
- 公司行业：机械/设备/重工
职位信息
- 发布日期：2022-06-24
- 工作地点：北京
- 工作经验：8-9年经验
- 学历要求：本科
- 职位月薪：2-3万
- 职位类别：医疗器械生产/质量管理
职位描述
Position Summary | |||||||||
· This position is a core team member to drive the IOL product and import product for China registration · Develop and execute product registration strategy in line with company business goals and maximize competitive advantages of company assets · Develop and execute continuous improvement recommendations on standard/product technical guidance and provide insights to stakeholder and dedicated RA team · Build and maintain good and professional relationship with regulatory authorities to ensure smooth and efficient registration process and make possible positive change of regulatory environment. § Develop and implement RA strategy for China registration, esp to communicate with Chinese authority & global team on product compliance to ensure submission and approval in line with biz plan to enable biz growth § Advocate insights for specific emerging standard/technical guidance/regulatory requirement to RA team and stakeholder, collaborate with team to build and execute relevant RA process/WI to ensure compliance § Communicate standard/technical guidance changes to global RA/CA in a timely manner, and provide insights in meetings and complying with new requirements for projects under assigned team § Enhance and maintain good relationship with Chinese authorizes to facilitate review and approval effectively, take initiatives to work closely with standard committees/relevant parties to advise comments as key opinion leader in draft stage on behalf of Zeiss from technical perspective § Leverage internal and external resources for RA strategy & plan in meeting registration requirements and advice regulatory requirements during product design stage proactively. § Additional tasks as assigned by RA function head § This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site). Education A Master/Bachelor’s Degree in medical/science Experience 8+ years working experience in the medical field, and IOLs registration experience will be preferred. Other skills - Good communication, facilitation and problem-solving skills - Communicate effectively in English both verbally and in written form. Good computer skills, profeciency in office software - Strong strategic problem-solving and project management skills. - Strong cross-function collaboration capability and good teamwork sprit - Proven record of successful completion of complex tasks. - Familiar with NMPA regulations/standards/technical guidance, and international regulations/standards， FDA, MDD, JPAL, KFDA regulation knowledge will be preferred - Knowledge of ISO13485/ ISO14971/ISO14155 will be preferred - Familiar with ophthalmic devices is preferred - Willing to travel if necessary. |
职能类别：医疗器械生产/质量管理
公司介绍
蔡司是全球光学和光电行业领先的科技企业。上一个财年，蔡司集团半导体制造技术、工业质量与研究、医疗技术、光学消费品市场四大业务部门的总营收额75亿欧元（截至2021年9月30日）。
蔡司致力于为客户开发、生产和行销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。
蔡司的产品组合与数字化、医疗及工业4.0等未来增长领域的发展趋势一致，同时也拥有一个强大的品牌。凭借于此，蔡司正以其解决方案塑造技术的进步，并不断拓展光学及其相关领域的边界。公司在研发方面进行的可持续且大量的投入，为公司的成功、蔡司技术的不断拓展和市场领先地位奠定了坚实的基础。蔡司将其营收的13%投资于研发——这样高水平的研发投入在蔡司有着悠久的传统，这也代表了公司对未来的投资。
蔡司在全球拥有逾35,000名员工，约60个销售和服务公司、30个生产基地及27个研发基地分布于近50个国家。公司于1846年在耶拿成立，总部位于德国奥伯科亨。卡尔蔡司基金会是德国***的基金会之一，致力于促进科学的发展，同时也是控股公司卡尔蔡司股份公司的***所有者（截至2021年9月30日）。
蔡司大中华区
蔡司于1957年进入中国，目前蔡司集团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。中国区是蔡司集团快速增长的市场之一，我们在大中华区共有近5500位员工，分布于各地的5个生产基地和6个销售与服务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***企业级创新研发中心，同时具备面向整个国内市场的中央物流与仓储功能，全面支持中国本土研发与生产，积极拓展合作领域，深耕中国市场。
公司提供上下班班车。
联系方式
- 公司地址：天河区珠江东路16号高德置地冬广场G座3802室