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法规事务主管 Regulatory Affairs Supervisor

法规事务主管

Regulatory Affairs Supervisor


主要职责 Key Responsibilities

1.负责产品注册,包括文件准备、测试、提交和技术审查、问答等,及时获得注册证。

Visit user group (hospitals, dealers, rehab centers, communities, etc.) in the area.

2.及时向集团质量及法规部门、市场部门及其它利益相关者提供反馈。

Provide timely feedback to global quality and regulatory, marketing and other related stakeholders.

3.及时向亚洲主要国家提供法规支持。

Provide prompt support to key countries in Asia.

4.负责注册评估并协助管理当地代理/CRO。

Be responsible for regulatory assessment and support the management of local agents/CROs.

5.收集国内外注册相关法规,制定注册计划并管理注册文件等。

Maintain and develop regulatory related requirement, apply appropriate plans and manage the documents.

 

 主要要求Key Requirements

1.6年以上跨国医疗器械(有源)注册经验。

6 years’ experience in medical device registration (active device) in multinational companies.

2.优秀的沟通和多项目管理能力。

   Excellent communication skills and multiple projects management.

3.良好的注册法规文件写作能力。

   Good regulatory writing skills.

4.优秀的团队合作及细节管理。

  Good teamwork spirit and detail oriented.

5.优异的中文及英语能力。

   Proficient in Chinese and English.

 

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China - Beijing


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