下述职责不代表高级法规事务专员的全部工作和职责范围，旨在说明该职位的人选应具备的基本素质。旨在表明高级法规事务专员应有能力并愿意承担任何工作任务。 Responsibilities listed below do not represent the full scope of duties and responsibilities, but aims to be representative of the fundamentals expected of a Senior RA Specialist. It is implied that a Senior RA Specialist would be competent, and willing to undertake any task expected. + 制定和管理项目注册工作，着重于制定注册项目计划和开展具体的注册工作。 Develop and manage project registration activities focused on the development of registration project plan and execution of detailed registration activities. + 准备注册资料和技术要求文件。 Prepare registration dossier and technical requirement document. + 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。 Work closely with project team to ensure registration activities meeting project timeline. + 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。 Define priorities together with line manager on assigned projects or across multiple projects, for RA and cross functional project team members. + 及时提供 高质量 的苏州文件，以支持国际注册工作。 Support the international registration by providing outstanding Suzhou documents on time. + 支持生产和研发工作，并及时 审阅 相关变更。 Support the manufacturing and R&D activities and review related changes on time. + 全球法规事务部的协助下， 支持产品转移，完成法规工作，包括产品分类、产地确定和时间表制定等。 Support the product transfer and complete the regulatory action including the classification, made in and timeline with the support from global RA. + 支持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。 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. + 支持 内部/ 外部审计。为团队提供法规指导。 Support the internal/external audit. Provide regulatory guidance to team. + 与内部合作伙伴，包括全球法规事务部，本地质量、研发和生产部门保持良好关系。与这些职能部门合作伙伴有效 地 沟通。 Maintain the relationships with internal partners, including global RA, local quality, R&D and Manufacture. Effectively communicate with these functional partners. + 鉴别、评估并专业解读新政策与法规，以支持 产品 开发 和注册。 Identify, evaluate and professionally interpret new policies and regulations for product development and registration. + 提供法规和政策走向方面的咨询与说明。 Provide consultation and direction regarding regulation and policy trends. + 积极参与到 国行标制修订的 相关活动中，支持强生项目和业务。 + Actively participant in the creation and revision of GB/YY standard, to support J&J projects and business. + 起草公司相关流程，以提高产品注册效率和质量。 Draft company related procedures to improve product registration efficiency and quality. + 了解并遵守强生的信条和基于信条价值观的决策。执行公司和部门战略。 Understand and adherence to J&J Credo and value of Credo based decision. Execute company and departmental strategy. + 不断学习公司相关技术、政策和产品知识以及业务流程，以掌握职业技能并提高工作效率。 Keep learning company related technical, policy, product knowledge, business process to develop professional skill and work efficiency. + 严格保守公司机密信息并维护公司知识产权，包括产品研发信息、设计、生产流程、商业机密、政府汇报和法律事宜、销售额和市场策略。 Strictly maintain confidential information and intellectual property (IP) includes product development information, designs, manufacture process, trade secrets, government reporting and legal matters, sales volumes and marketing strategies. + 负责将业务相关问题或机会 沟通到上 一级管理层。 + Responsible for communicating business related issues or opportunities to next management level + 确保个人、并驱动公司对药监和公司相关 法规、政策和程序 的遵守。 + E nsur e persona l compliance, and drive for company compliance with Healthcare Authority and Company related regulations, policies, and procedures. + 与医疗器械监管部门的联络和沟通，如 N MPA、 C MDE、 J S MPA 等.。 + Connection and communication with medical device healthcare authority, such as NMPA, C MDE, J S MPA etc. + 执行其他必要的职责。 + Performs other duties assig ned as needed **Qualifications** Basic Requirement, including Education and/or Knowledge and/or Training and/or key Relevant Experience require d. 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） + 大学学位或研究生技术学位。 + University Degree or Post Graduate Technical Degree. + 必须具备/ Must Have + 2 年法规政策经验， 2 年合规经验， 2 年注册经验 + 2-year experience on policy, 2-year experience on compliance, 2-year experience on registration 3. Skill Sets and/or Training and/or Certification for the Special Position 特殊岗位的技能和/ 或培训和/ 或证书要求 + 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. + 精通中国和其他国家（如适用）的医疗器械法规和注册流程；熟知产品设计流程、产品特点、产品检测和生产流程相关知识。 Master China and oversea regulations (if applicable) of medical device and registration process, also master knowledge of product design process, product feature, product test and manufacture process. + 拥有良好的沟通能力和清晰的沟通策略，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 and clear communication strategy to influence internal and external decisions, by effectively utilize both written and oral communications or through presentations. + 展现出有效的时间管理能力、项目计划和管理能力。 Exhibits effective time management and project plan & management skills. + 具备运用战略思维和批判性思维独立解决问题的能力以及卓越的执行力。 Exhibits independent problem solving skill with strategic thinking and critical thinking, demonstrate excellent execution capability. + 诚实、积极、勤奋、专注，拥有较强的团队精神，高度自律，具备高度的主动性。 Honest, positive, diligent and dedicated, with excellent team spirit, highly disciplined, demonstrated high level of initiative. + 对新的法规、政策和技术充满好奇心和热情。 Curiosity and passion for new regulation, policy and technologies. + 精通医疗器械质量知识（ GMP、 GDP 等）。 Master medical device quality knowledge (GMP, GDP, etc). + 中英文流利。 + Fluent in both Mandar in and English.