Regulatory Affairs Operations Specialist – Korean Bilingual

Medtronic

. Coordinate the preparation, compilation, review, and submission of regulatory documentation for registrations, renewals, amendments, annual reports, and other regulatory activities .

Posted 10/14/2026full-timeRemote • Vietnam, PhilippinesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory documentation preparation, compliance monitoring, and cross-functional collaboration within the medical device or pharmaceutical sectors. Proficient in managing regulatory records and maintaining databases to ensure accurate traceability and adherence to regulatory requirements.

Highest-signal resume keywords

Regulatory Documentation PreparationRegulatory Compliance MonitoringKorean Regulatory Requirements KnowledgeRegulatory Database ManagementBusiness-Level English Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory OperationsQuality AssuranceClinical ExperienceRegulatory Submission ProcessesDocument Review and AccuracyRegulatory Labeling ActivitiesRegulatory Record MaintenanceSubmission Timeline MonitoringRegulatory Activity TrackingTechnical Writing

Soft Skills

CollaborationOrganizational SkillsCommunication Skills

Tools & Technologies

Microsoft OfficeExcelWordPowerPoint

Industry Keywords

Medical DevicePharmaceuticalContract Research OrganizationRegulated EnvironmentRegulatory Activities

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Benefits

Comp & perks

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