Job Summary
This role focuses on monitoring, analyzing, and interpreting Chinese medical device regulatory updates, including NMPA regulations, national standards, and industry norms. The incumbent will assess the impact of regulatory changes on the company’s product lifecycle, develop China-specific regulatory intelligence strategies, and provide actionable insights to senior management and cross-functional teams (R&D, RA, QA, Marketing) to support business decision-making. Additionally, the role involves maintaining a regulatory intelligence repository, conducting internal training, liaising with Chinese regulatory authorities and industry associations, and ensuring the company’s operations in China fully comply with all relevant regulatory requirements.
Education and Qualification
- Bachelor degree and above
- Good English communication skill
- Overal 15 years working experience with 10 years and above working years in relevant experience in Medical industry.
- Previous RA or government agencies working background are preferred