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医疗器械注册工程师 (MJ005760)

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医疗器械注册工程师 (MJ005760)

昆明贝泰妮生物科技有限公司

医疗器械注册工程师 (MJ005760)

2 months ago

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Important information


Contract type:

Permanent

Location:

Shanghai, China

Work mode:

Onsite

Published on:

3 September 2026

What they need


该职位来源于猎聘 岗位职责: 1、协助医疗器械注册事务:配合完成医美植入类器械注册 / 变更、备案资料整理、资料校对、申报资料归档,跟进在申报项目进度,整理注册相关台账; 2、维护已上市产品注册相关合规资料,对接销售业务侧,基于注册文件、技术资料,完成对外产品资料转化; 3、输出产品介绍、合规宣传素材、销售答疑口径,确保输出资料符合医疗器械法规要求; 4、收集 NMPA 相关法规更新,整理法规要点,协助内部合规宣导;协助处理注册相关沟通、资料递交准备工作; 5、跨部门协同:对接研发、生产、销售团队,完成资料流转、信息同步,完成领导交办的其他注册及合规支持工作; 任职要求: 1、本科及以上学历,生物医学工程、药学、生物工程、医疗器械、材料等相关专业,2026 届应届生可,有无器械注册经验均可; 2、了解医疗器械基本法规优先(NMPA、注册管理办法等),愿意学习医美植入类器械注册业务; 3、具备较好的文字功底,擅长资料整理、文案转化,逻辑清晰,细心严谨,对文档合规性有敏感度; 4、沟通能力良好,可以对接销售业务部门,理解业务需求并转化合规输出物; 5、熟练使用 Office 办公软件,做事踏实有责任心,能够接受多任务并行。

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