职位描述
工作职责:
Responsible for post market product compliance, include but not limited to the medical device products.
Be able to collect, monitor, analyze and interpret relevant regulations, product industrial standards and national standards professionally
Responsible for the Chinese labeling including templates design, data constructing for the import products
Host the post market audits
Maintain the GSP master data and responsible for the initial approval of suppliers/customers in GSP
Other post-market product compliance relevant tasks
任职要求:
Bachelor degree.
Minimum of Five (5) years’ experience in the Medical Device industry or associated manufacturing or service industries.
Comprehensive knowledge of Quality System standards and quality system related regulations including but not limited to China GSP, 21 CFR 820, and ISO 13485.
Thorough understanding of quality science, knowledge of continuous improvement methodologies, knowledge of quality systems
Excellent communication skills
Problem identification, analysis, providing solutions
Fluency in English both on speaking and writing.
企业介绍
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services. For more information, please visit www.thermofisher.com.