At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https: //www.jnj.com

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1. Principal Duties and Responsibilities (General Summary, essential functions and authorities, etc.)
主要工作职责（基本概况，主要功能，权限等）
 Align with company and commercial strategy, direct, develop and manage project registration activities focused on the define registration (and renewal) strategy, registration project plan, supervision on project execution and delivery.
 基于公司和业务策略，指导、开发和管理项目注册工作，着重于制定注册（和延续注册）战略、注册项目计划，监督项目执行与交付。
 Manage day-to-day operation to ensure registration related projects/programs progress. Review and approve required information for the registration dossier and technical requirement document.
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 管理日常运营，以确保注册相关项目/计划的流程妥善实施。审批注册资料和技术要求文件所需信息。

 Assign and allocate resources and actively oversee departmental (team) projects. Provides managerial leadership & direction to assigned team allowing appropriate prioritization of resources to achieve goals.
 分配和配置资源，积极监督部门（团队）项目。给指定团队提供管理层面的引导与指导，允许适当的资源优化配置以实现目标。
 Interact and proactively forge new relationships with external partners, including global regulatory functions, quality, R& D, manufacture and commercial partners, Effectively communicates with franchise and local cross functional leaders.
 与公司外部合作伙伴，包括全球法规部门、质量、研发、生产和商业伙伴互动并积极建立新关系。和总部及当地跨职能部门负责人有效沟通。
 Establish and maintain relationship with NMPA and other authorities, manage and maintain clear and effective internal-external communication channel.
 与NMPA以及其他监管部门建立并维持良好关系，管理并维护内-外部之间的有效沟通渠道。
 Provide regulatory support for cross functional departments and cultivate company regulatory compliance environment.
 为跨职能部门提供法规支持，并营造公司法规合规运营环境。
 Identify, evaluate and interpret new policies and regulationsand standard.
 发现、评估并解读政策法规和标准等方面的新政策与法规。
 Lead policy shaping, standard improvement etc. to support JnJ project and business.
 领导制定政策、标准改进等工作，以支持强生项目和业务。
 Propose plan & implement improvements to company related procedures improve product registration efficiency and quality.
 针对公司相关程序提出计划并实施改进措施，以提高产品注册效率和质量。
 Cultivate a collaborative, trusting and ethical working environment that positively contributes to employee engagement and capability development within RA department and cross functional team.
 在法规事务部内和跨职能团队营造合作、互信、有职业道德的工作环境，积极提升员工参与度和能力发展。
 Guide team to understand and adherence to J& J Credo and value of Credo based decision. Delivery and lead on execution on company and departmental strategy.
 引导团队了解并遵守强生信条和基于信条价值观的决策。带头执行公司和部门战略并交付成果。
 According to company requirement and policy, Recruit, select, develop staff and provide on-going performance management and periodic formal evaluation.
 根据公司相关要求和政策，招聘、选择、培养员工，进行持续的绩效管理并定期进行正式评估。
 Design and apply effective professional/personal development plans for staff, to develop job required capabilities, facilitate competencies improvement and career development for staff.
 为员工设计并运用有效的职业/个人发展计划，以确保员工掌握工作所需的能力, 为员工提供能力提升和职业发展机会。
 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、销售量和市场策略。
 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。

2. Basic Requirement, including Education and/or Knowledge and/or Training and/or key
Relevant Experience required.
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）
 B.S. in medical, material, mechanical/biomechanical engineering or pharma. An advanced degree (Masters) in above subjects is strongly preferred. MBA and/or PhD is a plus.
 拥有医学、材料学、机械/生物机械工程或制药专业学士及以上学位。以上领域高学历（硕士）优先。
 More than 5 years RA experience in medical device industry.
 在医疗器械行业拥有5年以上法规事务经验。

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
 Master China and oversea regulations (if applicable) of medical device and registration process, familiar with knowledge of product design process, product feature, product test and manufacture process.
 精通中国和其他国家的医疗器械法规（如适用）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。
 Strong people management & leadership skills, strong organization, planning, coordination and execution ability; keen observation ability, strong comprehensive analysis ability.
 拥有较强的人员管理和领导能力，较强的组织、计划、协调和执行能力；敏锐的观察力、良好的综合分析能力。
 Demonstrated ability to build lasting cross-functional relationships, including strong influential and strong communication skills to impact industry/agency organization decisions, by effectively utilize both written and oral communications or through presentations.
 展现出建立长期跨部门关系的能力，包括较强的影响力和沟通能力，可通过有效的书面和口头沟通或演示影响行业/机构组织的决策。
 Exhibits excellent time management and project management skills.
 展现出良好的时间管理能力和项目管理能力。
 Ability to manage and allocate resources to assigned projects which result in completing projects on time and within budget.
 能够管理所分配的项目并配置资源，使得项目按时完成且将成本控制在预算之内。
 Ability to effectively use coaching, mentoring, negotiation and conflict management skills to ensure delivery of regulatory deliverables.
 能够有效使用辅导、指导、谈判和冲突管理技能确保法规可交付成果的交付。
 Ability to develop and apply effective professional/personal development plans for staff, which results in enhanced job competencies and motivation.
 能够为员工制定并运用有效的职业/个人发展计划，以提升工作能力和动力。
 Demonstrate excellent skills of critical thinking and strategic thinking, change management leadership and risk assessment, including ability to integrate overall business objectives into the goals / vision / values of department, and communicate these effectively.
 展现出良好的批判性思维能力和战略思维能力，改变管理领导力和风险评估能力，包括将整体业务目标融入部门目标/远景/价值观并有效传达的能力。
 Excellent problem solving and demonstrated excellent execution capability.
 卓越的问题解决能力和执行力。
 Honest, positive, diligent and dedicated, with excellent team spirit and overall vision, highly disciplined, demonstrated high level of initiative.
 诚实、积极、勤奋、专注，拥有较强的团队精神和全局观，高度自律，拥有高度的主动性。
 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。
 Fluent in both Mandarin and English. 中英文流利。