Regulatory Affairs SME

在捷普，我们打造品牌，打造世界——这也就是为什么我们会成为技术上最领先和最可信赖的制造解决方案提供商。不管我们服务的对象是全世界最大最知名的品牌还是最新潮的技术初创公司，我们的决心永远不会动摇。我们与这些品牌的愿景是相一致的，那就是：打造一个更好的、更安全的、更干净的地球。

At Jabil (NYSE: JBL), we are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, supply chain, and manufacturing solutions. With 60 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.

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.

捷普，包括其子公司，是一个就业机会均等的雇主，在考虑候选人是否符合雇佣标准时，种族、肤色、宗教信仰、国籍、性别、性取向、性别认同、性别、年龄、残疾、遗传、退伍军人身份和其他所有受法律保护的特征均不会被考虑在内。

Accessibility Accommodation

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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