招聘人数：1-2人
到岗时间：不限
年龄要求：不限
婚况要求：婚姻状况
语言要求：
英语
Senior RA Specialist is under the supervision from their line manager. They will be responsible for planning, execution, and delivery of multiple RA projects to achieve significant company goals. Senior RA Specialist implement the registration strategy and develop the registration project plan based on strategy, execute the registration activities for assigned projects under their line manager’s supervision. They coordinate activities of various cross-functional departments including research & development, manufacturing, quality, medical, clinical, legal, and other functions to meet the needs of project registration. This role requires regulation and product knowledge, coordination, communication skills and execution which directly impact the operational results of the business unit.
高级法规事务专员由其直线经理监督管理。高级法规事务专员负责多个法规事务项目的计划、执行和交付，以实现公司重大目标。高级法规事务专员负责在直线经理的监督管理下针对所分配的项目执行注册策略，根据策略制定注册项目计划，并开展注册工作；负责协调不同跨职能部门之间的工作，包括研发、生产、质量、医疗、临床、法务以及其他职能部门，以满足项目注册之需要。本职位要求具备相应的法规和产品知识、一定的协调能力、沟通能力与执行能力，这些都会直接影响业务部门的运营结果。
KEY RESPONSIBILITIES/TASKS (indicate estimated % of time spent where possible)/ 主要职责/任务 (以时间的百分比表示)
60% Product registration preparation & execution. 60% 产品注册准备和执行。
20% Develop registration project plan. 20% 制定注册项目计划
10% Lead & support regulatory compliance activities. 10% 领导并协助法规合规工作。
10% Regulatory intelligence collection, interpretation and policy shaping. 10% 法规信息收集、解读和政策制定。
ACCOUNTABILITIES/KEY MEASURES/职责/主要衡量指标
Develop and manage project registration activities focused on the development of registration project plan and execution of detailed registration activities.
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。
Prepare registration dossier and technical requirement document.
准备注册资料和技术要求文件。
Work closely with project team to ensure registration activities meeting project timeline.
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。
Define priorities together with line manager on assigned projects or across multiple projects, for RA and cross functional project team members.
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。
Support the international registration by providing outstanding Suzhou documents on time.
及时提供完成的苏州文件，以支持国际注册工作。
Support the manufacturing and R&D activities and review related changes on time.
支持生产和研发工作，并及时审查相关变更。
Support the product transfer and complete the regulatory action including the classification, made in and timeline with the support from global RA.
支持产品转移，完成法规工作，全球法规事务部的协助下进行包括产品分类、产地确定和时间表制定等工作。
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 internal/external audit. Provide regulatory guidance to team.
协助内部/外部审计。为团队提供法规指导。
Maintain the relationships with internal partners, including global RA, local quality, R&D and Manufacture. Effectively communicate with these functional partners.
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沟通。
Identify, evaluate and professionally interpret new policies and regulations for product development and registration.
鉴别、评估并专业解读产品研发和注册方面的新政策与法规。
Provide consultation and direction regarding regulation and policy trends.
提供法规和政策走向方面的咨询与说明。
Take the initiative and lead the discussion in standard improvement etc. to support JnJ project and business.
发起并领导国行标制修订的讨论等工作，以支持强生项目和业务。
Draft company related procedures to improve product registration efficiency and quality.
起草公司相关流程，以提高产品注册效率和质量。
Understand and adherence to J&J Credo and value of Credo based decision. Execute company and departmental strategy.
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。
Keep learning company related technical, policy, product knowledge, business process to develop professional skill and work efficiency.
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。
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.
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。
All work will be carried out in accordance with company policies and procedures. Ability to comply with the Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations.
所有工作均须按照公司政策和程序予以开展。能够遵守质量管理体系、质量管理政策、质量目标和相关法律及法规。
B.S. or above in medical, material, mechanical/biomechanical engineering or pharma.
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。
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.
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。 Good communication skills and clear communication strategy to influence internal and external decisions, by effectively utilize both written and oral communications or through presentations.
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。
Exhibits effective time management and project plan & management skills.
展现出有效的时间管理能力、项目计划和管理能力。
Exhibits independent problem solving skill with strategic thinking and critical thinking, demonstrate excellent execution capability.
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。
Honest, positive, diligent and dedicated, with excellent team spirit, highly disciplined, demonstrated high level of initiative.
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。
Curiosity and passion for new regulation, policy and technologies.
对新的法规、政策和技术充满好奇心和热情。
Master medical device quality knowledge (GMP, GDP, etc).
精通医疗器械质量知识（GMP、GDP等）。
Fluent in both Mandarin and English.
中英文流利。
求职提醒：求职过程请勿缴纳费用，谨防诈骗！若信息不实请举报。
