China RA&QA Specialist
- 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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