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Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

职 位：法规事务合规专员

工作地点：北京

职位介绍

1. 作为RA业务伙伴，提供RA注册过程中的合规及流程支持及本地化策略评估
2. 在注册项目过程中，集中管理产品标识信息，确保产品标识信息符合中国法规、标准及公司要求
3. 领导/协调开展RA内部及跨部门项目，主动寻求解决方案，持续满足法规要求及公司新模式下需求

工作职责

1. 为RA提供合规及流程支持，识别注册项目中产品标识、本地化相关的关键确认点，完善内控流程，持续提升递交资料质量
2. 集中管理产品标识（包含中文说明书和中文标签），维护本地化相关系统信息，使用现有本地化系统和程序，并提出解决方案/改进建议
3. 为其他波士顿科学人员提供本地化、产品标识方面法规支持，以促进跨部门的合作
4. 结合后市场监管要求，协助完善RA注册流程，主动识别可行方案并落地
5. 协助提升注册项目追踪数据质量及注册相关注册数据准确性
6. 支持质量政策，将质量融入工作的各个方面，并保持遵守所有质量要求
7. 在经理的指导下，计划，组织并完成日常工作

任职资格

1. 1-3年医疗器械、制药行业RA/QA工作经验
2. 具备良好的合规意识，识别和解决问题的能力，快速学习能力
3. 熟练应用办公应用，有一定的数据分析能力
4. 善于沟通与跨部门合作
5. 良好的英文读写能力

Requisition ID: 590178

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!