China RA&QA Specialist

Responsibilities:

  • Execute regulatory plans for registration projects including new products, renewal of licenses / authorizations and amendment projects.
  • Prepare, classify and verify the relevant documents for registration application.
  • Maintain the long-term professional relationship / partnership with all the external customers (NMPA, local MPA Test center, National Standard & relevant Industrial association, consultants, etc.).
  • Interface with NMPA, and global RA for procuring updates and results of sample tests associated with registration of products.
  • Participate in audits from NMPA or other country regulatory bodies.
  • Act as liaison between NMPA or other country regulatory bodies, our local consultants, and global RA. 
  • Keep current with industry RA and NMPA or other regulatory body regulations and changes and Keep global RA.
  • Establish appropriate and effective communication within RA and other functions and ensure that project objectives and deliverables are meeting timelines.
  • Coordinate with partners i.e. GE healthcare China, Siemens healthcare China.
  • Implement PMS regulations to ensure ongoing compliance:
  • Develop local Quality Management System (QMS), to be working in alignment with HQ QMS from the GMP&GSP perspective. The role may include writing, reviewing, updating and promoting SOPs and any other associated documentation and deploying quality related systems.
  • Handle local complaints and AE reporting.
  • Review local labeling materials (labels and IFUs) to ensure they meet country requirements and is in compliance with the specific international country labeling requirements.
  • Provide on-going support to China team on compliance and quality issues.
  • Coordinating and supporting as required

Skills and experience:

  • Education background of medical science or technology.
  • Minimum of 5 years of working experience in RA&QA in medical field.
  • Minimum of 2 years of experience working with foreign companies
  • Regulatory & QA requirements training.
  • Good learning ability
  • Good English communication ability;
  • Good judgment, decision-making and communication skills;
  • Good technical understanding
  • Good English and Chinese technical writing ability

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