Regulatory Affairs Operations Specialist – Korean Bilingual

• Coordinate the preparation, compilation, review, and submission of regulatory documentation for registrations, renewals, amendments, annual reports, and other regulatory activities
• Manage the tracking, indexing, archiving, and maintenance of paper and electronic regulatory records and submissions
• Review submission documentation for completeness, accuracy, and compliance with regulatory requirements and internal standards
• Collaborate with cross-functional stakeholders to collect, organize, and maintain documentation supporting regulatory filings
• Monitor regulatory activities, submission timelines, and system records to support compliance and reporting requirements
• Support regulatory labeling activities by providing recommendations aligned with applicable regulatory requirements
• Maintain regulatory databases, systems, and tools to ensure accurate documentation and traceability of regulatory information
• Monitor regulatory changes and communicate relevant updates that may impact submission strategies, processes, or compliance activities

• Bachelor's Degree in Medical Sciences, Biological Sciences, Engineering, or a related technical discipline
• Minimum of 3 years of regulatory, regulatory operations, quality, clinical, or related experience within a medical device, pharmaceutical, contract research organization (CRO), or similar regulated environment
• Business-level English proficiency in reading, writing, and speaking
• Korean language proficiency equivalent to TOPIK II Level 3 or Level 4, with the ability to read, write, and communicate professionally in Korean
• Knowledge of Korean regulatory requirements and regulatory submission processes
• Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint

• Flexible Work Arrangement
• Medtronic Incentive Plan (MIP) short-term incentive
• Flexible Benefits Package
• Wide range of benefits, resources, and competitive compensation plans designed to support employees at every career and life stage