Senior Regulatory Affairs Manager – IVD (Head role, based in BJ or GZ/SZ)(注册事务高级经理, 驻北京或广州)

Senior Regulatory Affairs Manager – IVD (Head role, based in BJ or GZ/SZ)(注册事务高级经理, 驻北京或广州)

Work Location: Beijing or Guangzhou/Shenzhen

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
  • Min. 10 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
  • Excellent communication, analytical, & project management skills
  • Good command of Chinese (fluent Putonghua) and English

Interested parties please send your CV to winsome.choi@levin.hk by email or add connection via WeChat (WeChat: pthmdmcai).

Negotiable

10 years

Degree

Beijing/Guangzhou/Shenzhen


Enquiry: 852-25200103

To apply for this job, please send your CV to winsome.choi@levin.hk


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