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Regulatory Affairs SME

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职位编号
J2463258
地点
Shenzhen, China
类别
质量
发布日期
09/03/2026
工作时间类型
全职

在捷普(NYSE:JBL),我们很自豪能够成为世界顶级品牌值得信赖的合作伙伴,提供综合的工程、制造和供应链解决方案。凭借60年的跨行业经验和遍布全球的100多个工厂,捷普将全球覆盖影响力与当地专业知识相结合,提供可扩展和定制化的解决方案。我们的承诺超越商业成功,致力于构建可持续的流程,最大限度减少环境影响,并促进全球不同社区的繁荣与多样。

1. Assist Quality Manager to ensure functional management and business management is aware of and understands the principles and expectations associated

with the applicable regulations. 协助质量经理确保职能管理部门人员和业务管理部门人员了解和理解适用法规的原则和期望。

2. Assist Quality Manager in acting as a facilitator to site management in the standardization and simplification of the standards. 协助质量经理在标准化和简化标准方面作为公司管理的推动者。

3. Assist Quality Manager in Performing and documenting comprehensive risk assessment relating to regulatory affairs. 协助质量经理执行并记录与法规事务相关的综合风险评估。

4. Assist site manager to prepare packages for NMPA submission. 协助公司经理准备向中国药监局提交资料。

5. Assist and support Quality Manager when necessary in the development creation and documentation of world class quality and business system improvements, as

well as support for customer and /or ISO/FDA/NMPA escalations as needed. 必要时协助和支持质量经理开发创建和记录世界一流的质量和业务体系改

进,以及根据需要为客户和/或ISO/FDA/NMPA升级提供支持。

6. Solicit ongoing feedback from business units for effectiveness of regulatory support. 征求业务部门的持续反馈,以提高法规支持的有效性。

7. Assist to coordinate activities of medical initiatives as required and keep focused in times of crises. 根据需要协助协调医疗行业活动,并在危机时刻保持专注。

8. Coach and mentor the site to deliver regulatory affairs excellence to internal and external customers. 指导和培训公司向内部和外部客户提供卓越的法规事务。

9. Evaluates and schedules appropriate training programs and/or seminar for new/update regulation requirements. 对于新的/更新的法规要求,评估和安排适当的培训计划和/或讨论会。

10. Coordinate existing and future plant wide Quality System Improvement and certification programs. 协调现有的和未来的工厂质量体系改进和认证计划。

11. Maintain good communication and relations with government. 与政府部门保持良好的沟通和关系。

12. Must follow RBA and site EHS requirements. 必须遵守RBA职责和工厂EHS要求。

BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact your local police department. Any scam job listings should be reported to whatever website it was posted in.

Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, age, disability, genetic information, veteran status, or any other characteristic protected by law.

Accommodation Statement

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.

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