Compliance

• Support regional Regulatory team to provide design dossiers, technical writings for NMPA submissions.
• Interpret and apply applicable regulations, standards, and guidance documents to product development, manufacturing, and post-market activities.
• Serve as a regulatory subject matter expert for product development teams, providing guidance on regulatory strategies, design controls, risk management, and labeling requirements.
• Support post-market surveillance activities, including adverse event reporting, field actions, and regulatory responses to health authority inquiries.
• Review and approve labeling for regional expansion.
• Participate in internal and external audits.
• Collaborate effectively with cross-functional teams including R&D, Quality, Marketing, and manufacturing sites to achieve regulatory objectives.

Senior Specialist, Regulatory Affairs, Bilingual Mandarin Chinese

Compliance Specialist

Regulatory Operations Coordinator

Market Integrity Lead – Trade Surveillance Compliance

Regulatory Labeling Manager – NA, LATAM