Regulatory Affairs & QA Manager
深圳密易施贸易有限公司ShenzhenUpdate time: September 10,2019
Job Description
- The China subsidiary of a global market leader, an Israeli innovative dental company is now recruiting a Regulatory Affairs Coordinator.
Responsibilities and duties:
- Thorough understanding of the Chinese FDA registration requirements
- Communicating the requirements in a clear manner to the HQ Regulation department as well as other departments
- Hold meetings with the CFDA reviewers when required
- Actively seek solutions for technical issues arised during the registration process
- Prepare, write, edit & translate technical and clinical documents
- Perform routine QC and QA activities as required by the CDFA
- Maintaining the supervising the company internal working procedures to be aligned with the Chinese GDP
Key Requirements:
- Academic degree in medical/biological/technical field
- At least 3 year experience in medical registration- class 3
- Experience in dental – advantage
- Experience in dental implants- great advantage
- Good technical understanding & skills
- Able to look through the smallest details
- English – high writing skills & good spoken skills
- Willing to travel domestically and overseas frequently
- What we offer:
- Friendly and warm working environment
- Being a part of an innovative company
- Competitive salary & annual benefits
职能类别:医疗器械注册
关键字:注册法规医疗
上班地址:深圳市福田区沙头街道天安车公庙工业区天经大厦
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