RA Ops Specialist Korean Speaker

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

The Regulatory Operations Specialist (Korean Bilingual) supports regulatory submission and compliance activities by coordinating documentation, managing regulatory records, and collaborating with stakeholders across multiple functions. This role requires Korean language proficiency, knowledge of regulatory requirements in Korea, and the ability to manage multiple submissions and regulatory processes while maintaining accuracy and compliance.

Primary Responsibilities:

• Coordinate the preparation, compilation, review, and submission of regulatory documentation required 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 applicable 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.

Required Qualifications:

• Bachelor's Degree in Medical Sciences, Biological Sciences, Engineering, or a related technical discipline and a 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.

Preferred Qualifications:

• 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 Define, Measure, Analyze, Improve, and Control (DMAIC) or similar continuous improvement approaches.