Regulatory Affairs Operations Specialist – Korean Bilingual
Medtronic · National Capital Region, Philippines
RegulatoryFull-timeCompany career page
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Role summary
Medtronic seeks a Regulatory Affairs Operations Specialist with Korean bilingual capabilities to coordinate regulatory documentation, manage compliance records, and support product registration activities across markets. The role requires a technical degree, minimum three years of regulated industry experience, and professional-level proficiency in both English and Korean.
What they're looking for
- Bachelor's degree in Medical Sciences, Biological Sciences, Engineering, or related technical field
- Minimum 3 years regulatory, quality, clinical, or operations experience in medical device or pharmaceutical environment
- Business-level English proficiency in reading, writing, and speaking
- Korean language proficiency equivalent to TOPIK II Level 3 or Level 4
- Knowledge of Korean regulatory requirements and submission processes
- Proficiency with Microsoft Office applications including Excel, Word, and PowerPoint
What you'll be doing
- Coordinate preparation, compilation, review, and submission of regulatory documentation for registrations and renewals
- Manage tracking, indexing, archiving, and maintenance of paper and electronic regulatory records
- Review submission documentation for completeness, accuracy, and regulatory compliance
- Collaborate with cross-functional stakeholders to collect and organize regulatory filing documentation
- Monitor regulatory timelines, system records, and communicate relevant regulatory updates
Privacy & handoff
This role links to Medtronic's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.