Regulatory Affairs Specialist (NMPA) - Mandarin Chinese Speaking

📋 Description 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