Jobs / United States / Medtronic INC
Regulatory Affairs Operations Specialist – Korean Bilingual
Medtronic INC · 🇺🇸 2 Locations
Sponsorship verdict
Sponsorship possible
One solid signal, not two — worth applying, and worth asking about sponsorship early.
- Employer is on a government sponsor recordThe US Department of Labor certified 193 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 106 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
- The posting doesn’t mention sponsorshipSilence isn’t a refusal — ask the recruiter before investing much time.
- No salary bar for this routeH-1B has no fixed salary bar: the employer must pay at least the prevailing wage for the role and area. Cap-subject employers enter a lottery weighted by wage level. Source: https://www.federalregister.gov/documents/2025/12/29/2025-23853/weighted-selection-process-for-registrants-and-petitioners-seeking-to-file-cap-subject-h-1b, rules effective 2026-02-27.
- What Medtronic INC paid sponsored hires in similar roles8 certified filings for “Senior Regulatory Affairs Specialist” (Regulatory Affairs Specialists) in CA: $97k–$113k, median $106k. Most were filed at wage level III (71%) — 3 lottery entries, ≈46% projected selection odds for cap-subject employers. Source: US Department of Labor LCA disclosure data (Oct 2025 – Jun 2026).
- Confirmed live todayWhen a source last listed this job as open.
US H-1B: cap-subject employers enter a lottery weighted by wage level — Level I gets 1 entry, Level IV gets 4 (DHS projected selection odds ≈15% at Level I to ≈61% at Level IV). Universities and non-profit research employers are cap-exempt. The $100,000 fee for new petitions from abroad is currently blocked by a court order (appeal pending).
A verdict summarises public evidence; it is not legal advice and never a guarantee — the employer and the immigration authority decide. Sign in to factor in where you can already work.
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Sponsor Radar — Medtronic INC
The US Department of Labor certified 193 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 106 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
Past sponsorship or register membership never guarantees sponsorship for this vacancy or for you. Full Sponsor Radar for Medtronic INC →
About the role
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Regulatory Operations function supports the preparation, coordination, submission, tracking, and maintenance of regulatory documentation required to support product registrations and compliance activities across global markets. This team partners with cross-functional stakeholders to help ensure regulatory submissions are accurate, complete, and aligned with applicable requirements, while driving process efficiency and maintaining regulatory records and systems. 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). • Experie