商丘招聘

o 根据注册（以及延续注册）策略和注册项目计划，计划并执行项目注册工作。

o Plan and execute project registration activities according to the registration (and renewal) strategy, registration project plan.

o 准备注册资料和产品技术要求。

o Prepare the registration dossier and product technical requirement.

o 与项目团队密切合作，以确保注册工作按照项目时间表进行。

o Work closely with project team to ensure registration activities meeting project timeline.

o 与直线经理共同为法规事务部和跨职能项目团队成员确定项目或项目的优先级。

o Define priorities together with line manager on assigned projects or across multiple projects, for RA and cross functional project team members.

o 及时提供高质量的苏州工厂文件，以支持国际注册工作。

o Support the international registration by providing outstanding Suzhou documents on time.

o 支持生产和研发部门的工作，及时审阅相关变更。

o Support the manufacturing and R&D activities and review related changes on time.

o 支持产品转移完成法规相关工作，包括在全球法规事务部的协助下进行产品分类、产地确定和时间表制定。

o Support the product transfer and complete the regulatory action including the classification, made in and timeline with the support from global RA.

o 协助原材料和包装材料本地化项目和其他全球项目，在全球法规事务部的协助下进行法规影响评估。

o Support the raw material and packaging material localization projects and other global projects to provide the regulatory impact assessment with the support from global RA.

o 支持内部/外部审计。为团队提供法规指导。

o Support the internal/external audit. Provide regulatory guidance to team.

o 维护与内部合作伙伴，包括全球法规事务部，本地质量、研发和生产部门的合作关系。与这些职能部门的合作伙伴有效地沟通。

o Maintain the relationships with internal partners, including global RA, local quality, R&D and Manufacture. Effectively communicate with these functional partners.

o 鉴别、评估并解读新政策与法规，以支持产品开发和注册。

o Identify, evaluate and interpret new policies and regulations for product development and registration.

任职要求：

• 拥有医学、材料学、机械/生物机械工程或制药专业学士或以上学位。
• B.S. or above in medical, material, mechanical/biomechanical engineering or pharma.
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• 熟悉中国和其他国家（如适用）的医疗器械法规和注册流程；具备产品设计流程、产品特点、产品检测和生产流程相关知识。
• Familiar with China and oversea regulations (if applicable) of medical device and registration process, having knowledge of product design process, product feature, product test and manufacture process.
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• 拥有良好的沟通技巧，可通过有效使用书面和口头沟通或演示对外部及内部决策产生影响。
• Good communication skills to influence internal and external decisions, by effectively utilize both written and oral communications or through presentations.
• 中英文流利。
• Fluent in both Mandarin and English.

       FESCO，中国人力资源行业创始者，中国500强企业。为全球在华万余客户提供全方位人力资源解决方案,包括人事福利外包、招聘测评、外籍人服务、专业外包、专业咨询等。
    北京外企服务集团有限责任公司（FESCO）成立于1979年，是我国人力资源服务行业具有开创意义的***家企业。经过近40年发展，外企集团已经发展成为一个以人力资源外包服务为主，涉及旅游会展、文化传媒、房地产物业等相关领域的企业集团。