Korean-Speaking Regulatory Operations Expert

Medtronic International Ltd; Taguig; On-site; PHP 600,000 - 900,000; Full time

Job summary

Medtronic International Ltd in the Philippines seeks a Regulatory Operations Specialist (Korean bilingual) to coordinate regulatory submissions, maintain records, and collaborate with cross-functional teams to ensure compliant filings.

You will review documentation for completeness, monitor timelines, and support labeling and system updates, leveraging Korean language skills and knowledge of Asia-Pacific regulatory frameworks.

Qualifications

• Bachelor's degree in a technical field with 3+ years in regulatory operations within medical devices or pharmaceutical/regulated environments.
• Proficient reading, writing and speaking English; Korean language proficiency to TOPIK II Level 3 or 4.
• Knowledge of Korean regulatory requirements and submission processes.
• Proficiency with MS 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 regulatory compliance.
• Collaborate with cross-functional stakeholders to collect, organize, and maintain regulatory filings.
• Monitor regulatory activities, submission timelines, and system records to support compliance.
• Support regulatory labeling activities with recommendations aligned to regulatory requirements.
• Maintain regulatory databases, systems, and tools for accurate documentation and traceability.
• Monitor regulatory changes and communicate updates affecting submission strategies or compliance.

Skills

English proficiency

Korean language proficiency

Regulatory knowledge

Microsoft Office

Education

Bachelor's degree in Medical Sciences/ Biological Sciences/ Engineering or related

Tools

SAP

SharePoint

Regulatory information management systems

Document management systems

Job description

Medtronic International Ltd in the Philippines seeks a Regulatory Operations Specialist (Korean bilingual) to coordinate regulatory submissions, maintain records, and collaborate with cross-functional teams to ensure compliant filings.

You will review documentation for completeness, monitor timelines, and support labeling and system updates, leveraging Korean language skills and knowledge of Asia-Pacific regulatory frameworks.