China Regulatory Affairs Specialist
Core
Prepare, compile, review, and submit regulatory documentation for product registrations, renewals, and lifecycle management in Hong Kong and Macau; support international market registrations and post-market surveillance.
Role type
Regulatory Affairs Specialist
Builds
Regulatory dossiers and product registrations for assigned international markets
Domain
Medical Devices / Healthcare Regulatory Affairs
Required skills
Regulatory documentation preparation, submission coordination, license maintenance, post-market surveillance support, complaint handling, market access tracking
Preferred skills
International market registration experience, stakeholder coordination
Technologies
Regulatory databases, Quality Management Systems
Responsibilities
Prepare and submit regulatory dossiers for assigned international markets; Coordinate with internal stakeholders to obtain technical, quality, and clinical documentation; Maintain regulatory licenses, approvals, and product registration databases; Support responses to regulatory authority questions; Assist with complaint handling, investigation follow-up, and post-market surveillance activities.