Regulatory Affairs Specialist- Suzhou
Regulatory Affairs Specialist- Suzhou
Posted on :
22-08-2025
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1 Vacancy
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Job Description
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
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.
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
Good communication skills to influence internal and external decisions by effectively utilize both written and oral communications or through presentations.
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
Exhibits effective time management project management skills and risk management skills.
展现出有效的时间管理项目管理和风险管理能力
Exhibits problem solving skill with strategic thinking and critical thinking demonstrated excellent execution capability.
具备运用战略思维和批判性思维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.
诚实积极勤奋专注具有良好的团队精神高度自律
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
Have medical device quality knowledge (GMP GDP etc).
具有医疗器械质量相关知识GMPGDP等
Fluent in both Mandarin and English.
中英文流利
Plan and execute project registration activities according to the registration (and renewal) strategy registration project plan.
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
Prepare the registration dossier and product technical requirement.
准备注册资料和产品技术要求
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
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.
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
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的合作伙伴有效沟通
Identify evaluate and interpret new policies and regulations for product development and registration.
鉴别评估并解读与产品研发和注册相关的新政策与法规
Assist in providing consultation and direction regarding regulation and policy trends.
协助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以支持强生项目和业务
Understand and adherence to J&J Credo and value of Credo based decision. Execute 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提高职业技能和工作效率
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
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
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.
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
Good communication skills to influence internal and external decisions by effectively utilize both written and oral communications or through presentations.
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
Exhibits effective time management project management skills and risk management skills.
展现出有效的时间管理项目管理和风险管理能力
Exhibits problem solving skill with strategic thinking and critical thinking demonstrated excellent execution capability.
具备运用战略思维和批判性思维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.
诚实积极勤奋专注具有良好的团队精神高度自律
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
Have medical device quality knowledge (GMP GDP etc).
具有医疗器械质量相关知识GMPGDP等
Fluent in both Mandarin and English.
中英文流利
Plan and execute project registration activities according to the registration (and renewal) strategy registration project plan.
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
Prepare the registration dossier and product technical requirement.
准备注册资料和产品技术要求
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
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.
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
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的合作伙伴有效沟通
Identify evaluate and interpret new policies and regulations for product development and registration.
鉴别评估并解读与产品研发和注册相关的新政策与法规
Assist in providing consultation and direction regarding regulation and policy trends.
协助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以支持强生项目和业务
Understand and adherence to J&J Credo and value of Credo based decision. Execute 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提高职业技能和工作效率
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
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
Required Experience:
IC
Employment Type
Full Time
Key Skills
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