Work Location: Beijing

Job Highlights

• Class III IVDs registration in China
• Develop regulatory strategies, oversee and implement IVD kits development, and NMPA registration in China
• Good career prospect with attractive salary

Responsibilities

• Keep abreast of the NMPA regulation and develop strategies to speed up the approval
• NMPA Registration of new products in the category of IVD
• Regulation affairs of China site, include new products launch, changes, and renewal registration
• Liaise with R&D for document preparation and submission
• CRO vendor selection and management
• Uses knowledge and experience in the regulatory field to influence functional objectives
• Product compliance of post-marketing
• OEM manufacturer quality management in liaison with commercial

Requirements

• Science degree in Biotechnology or related fields
• 6 years of proven track record in regulatory affairs in China, preferably in class III IVD
• Experienced in the selection and managing OEM manufacturing, CRO vendors preferred
• Excellent communication, analytical, & project management skills
• Good command of Chinese (fluent Putonghua) and English

Interested parties please contact me / send your CV to winsome.choi@levin.hk or  WeChat 微信号: pthmdmcai).