Medtronic · 21 hours ago
Regulatory Affairs Specialist
United States
Full-time
Remote
Entry, Mid Level
$74K/yr - $110K/yr
2+ years expMedtronic is a global healthcare technology leader dedicated to solving challenging health problems. In the role of Regulatory Affairs Specialist, you will manage regulatory submissions and collaborate with cross-functional teams to ensure compliance and facilitate change management for diabetes products.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
Responsibilities
Coordinate and preparation of document packages for regulatory submissions from all areas of the company, internal audits, and inspections
Compile materials required in submissions, license renewal and annual registrations
Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance
Monitors and improves tracking / control systems
Keeps abreast of regulatory procedures and changes
May direct interaction with regulatory agencies on defined matters
Recommends strategies for earliest possible approvals of clinical trials applications
Qualification
Required
Minimum 2 years of experience with a Bachelor's Degree
Or, advanced degree
Preferred
Master's degree
Experience at Medtronic
Non-conformance Material Report (NCMR) or Product Review Board (PRB) experience
Experience in the medical device industry/manufacturing
Knowledge of EU MDR and US FDA Regulations
Medical Device Lifecycle
Good Documentation Practice (GDP)
ISO 13485
Experience writing FDA annual reports
Change Assessment
Project Management experience
Benefits
Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Company
Medtronic
Medtronic is a healthcare technology company that designs and develops AI-based products and solutions for the medical industry.
10001+ employees
H1B Sponsorship
Medtronic has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (349)
2024 (387)
2023 (291)
2022 (310)
2021 (300)
2020 (261)
Funding
Current Stage
Public CompanyTotal Funding
$18.16BKey Investors
NHS EnglandBlackstone Life SciencesTrade Capital Funding
2025-09-15Post Ipo Debt· $1.76B
2024-05-29Post Ipo Debt· $3.24B
2023-03-23Post Ipo Debt· $2B
Leadership Team
Geoffrey Martha
CEO and Chairman Of The Board Of Directors
Linnea Burman
SVP & President, Neurovascular
Recent News
2026-01-13
2026-01-13
Company data provided by crunchbase