Jobs / United States / Medtronic INC
Principal Regulatory Affairs
Medtronic INC · 🇺🇸 5 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
We anticipate the application window for this opening will close on - 8 Oct 2026 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 Principal Regulatory Affairs Specialist will play a key role in launching new products and sustaining the Wound Management product portfolio. As a new product development (NPD) core team member, the principal specialist works directly with the NPD team from the opportunity phase through commercialization. The principal specialist has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide for Wound Management devices. Sustaining regulatory responsibilities include reviewing product labeling changes to ensure that regulatory requirements continue to be met, documenting “no file” decisions, reviewing promotional materials, and ensuring that our product technical documentation is current and accurate. This position is most suited for individuals with a broad background covering the total regulatory life cycle of medical devices and strong working knowledge and experience with reviewing advertising and promotional materials for medical devices. Responsibilities may include the following and other duties may be assigned. • Provide regulatory affairs domain expertise and influence at all levels in support of the Wound Management device portfolio • Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering both domestic and international regulations • Prepare Pre-Sub and 510(k) submissions and technical documents to support CE mark and other international submissions • Participate in negotiations and interactions with regulatory authorities during the development and review process • Provide business and product information to the international regulatory affairs team to enable development and strategies and requirements and communicate that information to the business team • Support international product registrations as needed • Manage multiple projects and prioritize tasks on day by day basis to meet project schedules • Collaborated with engineering, quality, clinical, marketing, and other functions to fulfill responsibilities • Review promotional and advertising material • Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards • Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements • Participate in internal and external audits • Maintain regulatory affairs documentation to support compliance with applicable regulatory requirements • Perform other duties as assigned or required. Must Have: Minimum Requirements • Bachelor’s degree required • Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience. Nice to Have • Experience successfully achieving FDA clearance through a 510(k) submission • Experience interacting directly with the FDA • Experience managing or contributing to multiple regulatory submissions • Familiarity with medical device regulatory lifecycle management. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements