☆☆☆想要来注册部门实习的小伙伴请注意了
Job Description:
1. Work with global RA/QA team and product manager to complete Chinese IFU and Labeling.
与全球法规事务/质控部门及产品经理合作,完成符合国家食品药品监督管理局及卫计委要求的中文说明书标签。
2. Work with regulatory partner to achieve product licenses (CFDA registration and/or MOH
Certificate) for certain product lines;
通过与管理部门合作，完成产品注册并获得产品许可证；
3. Communicate with authorities, testing lab on product registration and technical requirements,
ensure license achieved timely;
与有关部门沟通，完成产品注册需要的测试实验和技术要求，确保准时获得产品许可证;
4. Draft products standards according to GB/YY/ISO standards and the other technical information in English;
根据GB / YY / ISO标准和其他英文产品技术资料撰写产品标准，
5. Manage product testing (test sample, test progress, test reports) conducted by Chinese testing lab to achieve test report for product registration;
进行产品测试（包括：测试样品，测试进度，测试报告）通过和中国实验室的配合获得实验报告并完成注册工作
6. Prepare and submit all the registration documents to CFDA and MOH;
准备和提交所有中国药监局和卫生部需要的注册文件
7. Maintain or develop good working relation with certification or testing lab, as well as relevant government department to improve working efficiency.
维持或发展良好的工作关系与认证或测试实验室,以及相关的政府部门
Qualification / Experience/ Skills Required
1. Bachelor's degree or above in related mechanical and electro - mechanical expertise background is preferred;
学士学位或以上学历,具有相关的机械和电-机械专业知识背景；
2. Strong written and oral communication in English and Chinese;
较强的中英文写作和口语沟通能力；
3. Sound basis of Regulatory knowledge and Scientific Knowledge;
具有良好的基础知识和科学知识
4. Ability to manage projects and timelines;
具有良好的项目管理和和时间管理能力
5. Good skill on Word, Excel and PowerPoint;
熟练使用office软件；
Working Location: Beijing;
工作地点：北京
Working Time:
At least 4 working days/ week.
每周至少工作4天。
欢迎感兴趣的同学们加入，要是表现优秀可以转正哦~
投递简历：347065952@qq.com
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FROM 222.128.78.*