上海招聘

ESSENTIAL JOB RESPONSIBILITIES:

• Be responsible for working
  with a cross functional team on the registration dossier preparation and
  submission based on product launch planning and NMPA requirement.
• Be responsible for
  registration test protocol preparation and work closely with testing lab
  to perform the registration test based on registration planning and
  authority requirements.
• Assesses changes in
  existing products and perform change registrations accordingly.
• Develops plan for timely
  renewal registrations to ensure continued product supply.
• Communicate closely with
  the Headquarters on the needs and problems of registration documentation
  and registration test.
• Follow up closely with CMDE
  and NIFDC, and report the progress of product registration.
• Build good network with
  relevant governments such as NMPA, NIFDC, and testing labs.
• Follow up closely with NMPA
  regulation related to registration.

TRAINING RESPONSIBILITIES: (REQUIRED)

• Complete
  all assigned and required training satisfactorily and on time

MINIMUM REQUIREMENTS:

Education and Experience (in years):

Medicine, Biology or Pharmaceutical related major, prefer to Molecular biology.

· 1-2 years working experience on medical, preferably on IVD registration.

Knowledge and skills:

· Skill of performing testing in lab. Experience on R&D or Lab testing work is preferred.

Other:

· Good English & communication skills.

· Ability and willingness to learn knowledge in related fields.

· Self-motivated and able to work independently in new developmental area

· Knowledge of NMPA guidelines.

Cepheid是一家领先的分子诊断公司，致力于研发、生产、销售精确易用的分子诊断系统和试剂盒，改善当前医疗状况。Cepheid将高度复杂而耗时的手工操作自动化，让各种规模的实验室更好地运行复杂的微生物基因测试和遗传病基因测试。Cepheid凭借强大的分子生物学平台，专注于最需要准确、快速和可为临床诊断提供依据的检测结果的应用领域，如传染病和癌症防治领域。