Regulatory Affairs Specialist
7 days ago
This role requires a highly skilled and experienced professional to oversee the medical device regulatory compliance process in China. The successful candidate will be responsible for ensuring that all products meet the required regulatory standards and will work closely with the global team to achieve this goal.
Key Responsibilities- Develop and implement regulatory strategies to ensure compliance with NMPA regulations
- Collaborate with the global team to achieve regulatory approval and license maintenance
- Compile and submit technical requirements and documents to NMPA
- Provide regulatory input for clinical evaluations and trials
- Support GCP and GMP inspections
- Monitor and update on Chinese and international medical device regulatory changes
- University degree in pharmacy, pharmacology, chemistry, medicine, engineering, or biological sciences
- At least 6 years of experience in medical device regulatory affairs
- Fluent in Mandarin Chinese and English
- Strong knowledge of NMPA regulations and requirements
AbbVie is an equal opportunity employer committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.
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