Korean Bilingual Regulatory Operations Specialist

Medtronic; Taguig; On-site; PHP 600,000 - 1,000,000; Full time

Benefits offered by this job

Competitive salary

Job summary

Medtronic is seeking a Regulatory Operations Specialist (Korean bilingual) in the Philippines to coordinate regulatory submissions, manage records, and ensure compliance across global markets. The role partners with multiple functions to gather accurate documentation and maintain systems.

The candidate will support labeling activities, monitor regulatory changes, and contribute to efficient regulatory processes while leveraging SAP, SharePoint, and MS Office tools.

Qualifications

• Bachelor's Degree in Medical Sciences, Biological Sciences, Engineering, or a related technical discipline with 3+ years in regulatory, regulatory operations, quality, clinical, or related experience in medical devices, pharma, CRO, or similar regulated environment.
• Business-level English proficiency in reading, writing, and speaking.
• Korean language proficiency equivalent to TOPIK II Level 3 or 4 with reading, writing, and professional communication in Korean.
• Knowledge of Korean regulatory requirements and regulatory submission processes.
• Proficiency with Microsoft Office applications (Excel, Word, PowerPoint).

Responsibilities

• Coordinate preparation, compilation, review, and submission of regulatory documentation for registrations, renewals, amendments, annual reports, and other activities.
• Manage tracking, indexing, archiving, and maintenance of 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 regulatory filings documentation.
• Monitor regulatory activities, submission timelines, and system records to support compliance and reporting.

Skills

English proficiency

Korean language

Regulatory operations

Microsoft Office

Education

Bachelor's Degree in Medical Sciences / Biological Sciences / Engineering

Tools

SAP

SharePoint

Regulatory information management systems

Excel

Word

PowerPoint

Job description

Medtronic is seeking a Regulatory Operations Specialist (Korean bilingual) in the Philippines to coordinate regulatory submissions, manage records, and ensure compliance across global markets. The role partners with multiple functions to gather accurate documentation and maintain systems.

The candidate will support labeling activities, monitor regulatory changes, and contribute to efficient regulatory processes while leveraging SAP, SharePoint, and MS Office tools.