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-timeHo Chi Minh City • VietnamMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory documentation preparation and compliance within the medical device and pharmaceutical sectors, with strong capabilities in managing regulatory records and collaborating with cross-functional teams. Proficient in Korean regulatory requirements and experienced in using regulatory information management systems.

Highest-signal resume keywords

Regulatory Documentation PreparationRegulatory Submissions ExperienceKorean Language ProficiencyRegulatory Information Management SystemsProcess Improvement Methodologies

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ComplianceRegulatory OperationsQuality AssuranceClinical ExperienceRegulatory Framework KnowledgeDocument ManagementRegulatory LabelingSubmission ReviewData AnalysisRegulatory Record Maintenance

Soft Skills

CollaborationCommunicationOrganizational SkillsAttention to DetailStakeholder Engagement

Tools & Technologies

Microsoft OfficeExcelWordPowerPointSAPSharePointRegulatory Information Management SystemsDocument Management Systems

Industry Keywords

Medical DevicePharmaceuticalContract Research OrganizationRegulated EnvironmentAsia-Pacific Regulatory FrameworksUS Regulatory RequirementsEU Regulatory RequirementsContinuous Improvement Approaches

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 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
Experience supporting regulatory submissions, registrations, renewals, or compliance activities for medical devices
Experience working with global stakeholders across multiple regions and functions
Experience using regulatory information management systems, document management systems, SAP, SharePoint, or similar business applications
Knowledge of medical device regulatory frameworks within Asia-Pacific (APAC), the United States (US), or the European Union (EU)
Experience applying process improvement methodologies such as DMAIC or similar continuous improvement approaches

Benefits

Comp & perks

Flexible Work Arrangement
Medtronic offers a competitive Salary and flexible Benefits Package
Wide range of benefits, resources, and competitive compensation plans designed to support every career and life stage
Eligible for a short-term incentive called the Medtronic Incentive Plan (MIP)