Regulatory Engineer
苏州工业园区全通贸易有限公司
- 公司规模：500-1000人
- 公司性质：外资(欧美)
- 公司行业：电子技术/半导体/集成电路 快速消费品(食品、饮料、化妆品)
职位信息
- 发布日期：2012-11-14
- 工作地点：苏州
- 招聘人数：1
- 工作经验：五年以上
- 学历要求：本科
- 语言要求：英语熟练
- 职位类别：认证工程师/审核员
职位描述
Position Summary:
The Regulatory Engineer is primarily responsible for Thermo Fisher Suzhou/Shanghai/Beijing manufactured product compliance to both China and oversea regulatory requirements.
Essential Job Functions and Accountabilities:
· Leading manufacturing license registration/Renew by working with SFDA on all medical devices/In Vitro Diagnostic Products
· Leading product compliance such as FDA, SFDA, UL, CSA, CE, NSF etc
· Familiar with clinical trial process
· Leading external and internal audits
· Implementation on quality system base on ISO9001&13485
· Managing product patent, brand
· Implement product compliance to RoHS/WEEE
Other Job Requirements: Regular travel is required, including international travel.
Educational Qualifications:
Master Degree, Major in biochemical background.
Experience Qualifications:
· Above 5 years experiences in product regulatory management in medical devices and IVD industry;
· Working experience with SFDA and UL is a must.
· Implementation experience in ISO9001&13485 is a must.
· Excellent oral and written communication skill in English, be able to work in a multicultural environment;
· Strong willing to learn, and self-motivated;
· Strong inter-personal skills;
The Regulatory Engineer is primarily responsible for Thermo Fisher Suzhou/Shanghai/Beijing manufactured product compliance to both China and oversea regulatory requirements.
Essential Job Functions and Accountabilities:
· Leading manufacturing license registration/Renew by working with SFDA on all medical devices/In Vitro Diagnostic Products
· Leading product compliance such as FDA, SFDA, UL, CSA, CE, NSF etc
· Familiar with clinical trial process
· Leading external and internal audits
· Implementation on quality system base on ISO9001&13485
· Managing product patent, brand
· Implement product compliance to RoHS/WEEE
Other Job Requirements: Regular travel is required, including international travel.
Educational Qualifications:
Master Degree, Major in biochemical background.
Experience Qualifications:
· Above 5 years experiences in product regulatory management in medical devices and IVD industry;
· Working experience with SFDA and UL is a must.
· Implementation experience in ISO9001&13485 is a must.
· Excellent oral and written communication skill in English, be able to work in a multicultural environment;
· Strong willing to learn, and self-motivated;
· Strong inter-personal skills;
公司介绍
苏州工业园区全通贸易有限公司诚聘