China Job Openings
Boston Scientific Corporation
RA Compliance Specialist
August 30, 2024
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 在经理的指导下,计划,组织并完成日常工作
- 1-3年医疗器械、制药行业RA/QA工作经验
- 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
- 熟练应用办公应用,有一定的数据分析能力
- 善于沟通与跨部门合作
- 良好的英文读写能力
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