Lead and manage China regulatory Affairs activities for product registrations and compliance across
Coordinate regulatory/clinical strategy, timelines, and cross-functional execution with ISI, JVRA
Prepare and review regulatory submissions, maintain registration trackers, and support audits.
Support China localization projects and PSURs with cross-functional teams.

🎯 Requirements

Hybrid onsite weekly in Sunnyvale, CA
Mandarin Chinese speaking required
Minimum 3 years RA experience
At least 1 year of NMPA/China GB/YY regulatory requirements and US FDA basics for medical devices
Experience with complex product development projects
Strong communication, cross-functional collaboration, and project management

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