Medtronic
Senior Regulatory Affairs Specialist - Onsite
Irvine, California, United States of America · Senior · Contract
Stay score
odds of building a lasting career here
Sponsors, but it's cap-subject — you still face the weighted lottery (~30% per draw at Level II). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
Personalize to your clock →H-1B wage level
the lottery is wage-weighted — each level is one more entry
$6,550 more — $98,550 — moves this role to Level III and 3 lottery entries. That figure is inside the range the employer already advertised.
Based on the DOL prevailing wage for this occupation and worksite, a base salary of $98,550 would place this position at wage Level III. That figure is within the posted range, and I'd like to target it. This role classifies under "Compliance Officers" for prevailing-wage purposes.
DOL prevailing wage, 2026-27 wage year · Compliance Officers (13-1041) · Los Angeles-Long Beach-Anaheim, CA. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
Employer immigration record
from this employer's Department of Labor filings
Green-card filing pattern in this occupation
Green-card follow-through: 63%
Files H-1B transfers
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
Community outcomes
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About the role
- We anticipate the application window for this opening will close on - 31 Oct 2026 Careers that change lives start here.
- Check us out on LinkedIn: Medtronic Neurovascular.
- This position is based in Irvine, California, and follows an onsite work model.
Responsibilities
- Manage regulatory data governance activities, including data quality reviews, discrepancy resolution, remediation efforts, and continuous improvement initiatives.
- Coordinate Unique Device Identification (UDI) activities and partner with Regulatory Affairs, Labeling, and cross-functional teams to maintain accurate device registration data.
- Lead or support cross-functional regulatory projects involving multiple products, product families, or regulatory teams.
- Support implementation, testing, validation, migration, reconciliation, and verification activities for regulatory systems and digital solutions.
- Partner with business and corporate stakeholders to implement process improvements, automation opportunities, and AI-enabled regulatory initiatives.
Requirements
- Experience managing projects, processes, or initiatives involving multiple stakeholders, products, or regulatory systems.
- Experience coordinating standards assessments and driving actions to completion with Regulatory Affairs and cross-functional subject matter experts.
- Experience evaluating regulatory impacts and maintaining compliance-related documentation, data, or business processes.
- Lead standards gap assessment processes, including assignment, tracking, documentation, stakeholder coordination, and completion of required actions.
Nice to have
- Experience with Unique Device Identification (UDI), global device registrations, EUDAMED, regulatory information management systems, or data governance.
- Experience supporting digital transformation, automation, analytics, or AI-enabled initiatives in a regulated environment.
- Experience assessing the regulatory impact of standards updates across product portfolios and supporting related change assessments.
- Experience leading cross-functional projects involving regulatory systems, process improvements, or enterprise initiatives.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
- Physical Job Requirements
- The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile.
Compensation
- and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
- Medtronic benefits and compensation plans
Benefits
- Bachelor's degree and 4+ years of regulatory affairs, quality, standards, or medical device experience OR Advanced degree and 2+ years of regulatory affairs, quality, standards, or medical device experience.
Company info
- U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact.
- Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. Recruitment Fraud Alert We are aware of phishing scams targeting job seekers.
Visa & Work Authorization
- U.S. Work Authorization & Sponsorship
This listing is sourced directly from Medtronic's careers page and normalized into a canonical job model.