Regulatory Affairs Operations Specialist – Korean Bilingual

🔥 6 minutes ago

🌐 Vietnam, Philippines – Remote

🇻🇳 Vietnam – Remote 🇵🇭 Philippines – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

⚙️ Operations

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Medtronic

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1949

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

Healthcare • Manufacturing • Healthcare Insurance

Medtronic is a global leader in healthcare technology solutions, working to address the most complex and challenging medical conditions. With over 95,000 employees in more than 150 countries, the company is focused on accelerating access to healthcare technologies and advancing inclusion, diversity, and equity in healthcare. Medtronic collaborates closely with healthcare professionals to innovate and optimize treatments and therapies, thus inspiring hope and new possibilities for patients worldwide. The company's commitment to healthcare extends to its focus on impactful solutions and sustainable practices.

📋 Description

• 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 relevant updates that may impact submission strategies, processes, or compliance activities

🎯 Requirements

• 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

🏖️ Benefits

• Flexible Work Arrangement • Medtronic Incentive Plan (MIP) short-term incentive • Flexible Benefits Package • Wide range of benefits, resources, and competitive compensation plans designed to support employees at every career and life stage