RAQA Engineer（欧美独资医疗设备行业公司，要求3年以上医疗行业工作经验，熟悉医疗法规注册）
上海帝博企业管理咨询有限公司
- 公司规模：少于50人
- 公司性质：外资(欧美)
- 公司行业：专业服务(咨询、人力资源、财会)
职位信息
- 发布日期：2013-06-20
- 工作地点：上海
- 招聘人数：1
- 工作经验：三年以上
- 学历要求：本科
- 职位类别：质量管理/测试工程师(QA/QC工程师)
职位描述
RAQA Engineer（欧美独资医疗设备行业公司，要求3年以上医疗行业工作经验，熟悉医疗法规注册，英语熟练）
工作地点：上海浦东
Purpose/Objective:
This position is responsible for implementing company regulatory policy and procedure, preparing submission documents in a timely and high quality manner.
Area of Responsibilities:
- Maintain the valid SH manufacturing license with no gap
- Drive complete process of product registration with the local FDA and other Chinese Government departments
- Lead the registration works related to new production and R&D projects
- Support the registration works related to product export
- Help the Company develop close relationships with Government Departments and Officials to facilitate the implementation of product registration strategies.
- Faciliate post market surveillance sampling
- Update quality files like Chinese labels and Manuals database to be compliance with SFDA regulations
Person Specification
Essential
- Bachelor degree or above
- Excellent written and oral communication skills
- Good command of English
- Familiar with Japan, Asia , USFDA and EU regulations
- Certified ISO QS auditor
- 2 years above hands-on experience with domestic product registrations of medical devices
- Quick learner
- manage time effectively, and handle multiple work pressures
- Can do altitude
Desirable
- Major in Biomedical preferred
- In vitro diagnostic regulatory experience preferred
- involve in RA works related to R&D preferred
- support RA works related product exportation preferred
工作地点：上海浦东
Purpose/Objective:
This position is responsible for implementing company regulatory policy and procedure, preparing submission documents in a timely and high quality manner.
Area of Responsibilities:
- Maintain the valid SH manufacturing license with no gap
- Drive complete process of product registration with the local FDA and other Chinese Government departments
- Lead the registration works related to new production and R&D projects
- Support the registration works related to product export
- Help the Company develop close relationships with Government Departments and Officials to facilitate the implementation of product registration strategies.
- Faciliate post market surveillance sampling
- Update quality files like Chinese labels and Manuals database to be compliance with SFDA regulations
Person Specification
Essential
- Bachelor degree or above
- Excellent written and oral communication skills
- Good command of English
- Familiar with Japan, Asia , USFDA and EU regulations
- Certified ISO QS auditor
- 2 years above hands-on experience with domestic product registrations of medical devices
- Quick learner
- manage time effectively, and handle multiple work pressures
- Can do altitude
Desirable
- Major in Biomedical preferred
- In vitro diagnostic regulatory experience preferred
- involve in RA works related to R&D preferred
- support RA works related product exportation preferred
公司介绍
DB Talent is a European based recruitment company. Our Shanghai office opened in the 2001, and we have continually provided excellent professional service to our clients and candidates.
联系方式
- 联系人：resume
- 电话：13701722965