迈德医疗科技(上海)有限公司
医疗器械国际注册专员
1 year ago
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Important information
Contract type:
Permanent
Location:
Shanghai, China
Work mode:
Onsite
Published on:
7 August 2026
What they need
该职位来源于猎聘 岗位职责 1、熟悉医疗器械欧盟认证流程，对相关法规、标准有一定了解； 2、负责公司产品的国外检验送检工作，确保符合欧盟法规及标准要求； 3、协助公司与公告机构联络，安排CE审核、并跟踪不合格项目整改进度，取得CE证书； 4、在指导下完成产品CE认证的资料准备、相关文件撰写、翻译及整理，确保产品认证工作顺利完成； 5、负责欧盟医疗器械法规及标准的收集与更新，及公司CE证书的维护； 6、完成上级交付的其他工作。 任职要求 1、一年以上医疗器械欧盟认证经验，有 MDR 2a/2b类申报经验优先 2、医疗器械、电子、生物学等理工科相关专业本科及以上学历 3、CET-6及以上，良好的英语书面表达能力 4、责任心强，具备一定的沟通协调能力
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