Regulatory Affairs Operations Specialist – Korean Bilingual
Core
Coordinate regulatory documentation preparation, submission, tracking, and maintenance for medical device product registrations and compliance across global markets.
Role type
Regulatory Operations Specialist (Korean Bilingual)
Builds
Regulatory submissions, compliance records, and documentation systems for medical devices
Domain
Medical device regulation (Korea, APAC)
Deliverable
client delivery
Required skills
Regulatory operations, documentation management, compliance monitoring, stakeholder collaboration, database maintenance, regulatory change tracking
Preferred skills
Medical device regulatory submissions, global stakeholder management, regulatory information management systems, SAP, SharePoint, DMAIC process improvement
Technologies
Microsoft Office (Excel, Word, PowerPoint), regulatory information management systems, document management systems, SAP, SharePoint