Responsible for post market product compliance, include but not limited to the medical device products.
More than 3 years Medical Device regulatory experience or post-market compliance experience.
Be able to collect, monitor analyze and interpret product relevant regulations professionally
Be able to collect, monitor, analyze and interpret product relevant industrial standards, national standards.
Responsible for preparing the Chinese labeling templates, review and approve Chinese labeling for the import products
Host the post market audits
Maintain the medical device distribution licenses.
maintain the GSP master data and responsible for the initial approval of suppliers/customers in GSP
Other post-market product compliance relevant tasks
Minimum Qualifications:
• Bachelor degree.
• Minimum of Five (5) years’ experience in the Medical Device industry or associated manufacturing or service industries.
• Comprehensive knowledge of Quality System standards and quality system related regulations including but not limited to China GSP, 21 CFR 820, and ISO 13485.
• Thorough understanding of quality science, knowledge of continuous improvement methodologies, knowledge of quality systems
• Excellent communication skills
• Problem identification, analysis, providing solutions
• Fluency in English both on speaking and writing.
