Regulatory Affairs Operations Specialist – Korean Bilingual
Core
Coordinate regulatory documentation preparation, submission, tracking, and maintenance to support product registrations and compliance across global markets.
Role type
Regulatory Operations Specialist
Builds
Regulatory submissions and compliance records for medical devices
Domain
Healthcare / Medical Devices / Regulatory Affairs
Required skills
Regulatory submission coordination, Documentation management, Compliance monitoring, Stakeholder collaboration, Database maintenance, Regulatory change tracking
Preferred skills
Medical device regulatory frameworks, Process improvement methodologies, Regulatory information management systems
Technologies
Microsoft Office, SAP, SharePoint
Responsibilities
Coordinate preparation and submission of regulatory documentation; Manage tracking and archiving of regulatory records; Review documentation for completeness and compliance; Collaborate with stakeholders to organize filing support; Monitor submission timelines and system records; Support regulatory labeling activities; Maintain regulatory databases; Monitor regulatory changes and communicate updates.