Medtronic · 18 hours ago
Regulatory Affairs Specialist
Minneapolis, Minnesota, United States of America
Full-time
Onsite
Entry, Mid Level
$74K/yr - $110K/yr
2+ years expMedtronic is a global leader in healthcare technology committed to alleviating pain and restoring health. They are seeking a Regulatory Affairs Specialist to develop strategies for worldwide product registration and provide regulatory support for new and existing products.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
Responsibilities
Providing advice on regulatory requirements
Preparing submissions
Negotiating their approval
Assisting with license maintenance, including annual reports, renewals, design/manufacturing change notifications, QMS audits, and manufacturing site registrations
Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products
Collaborate with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies
Prepare FDA, European, and Canadian submissions for product changes to ensure timely approval for market release
Review significant regulatory issues with the manager as necessary, and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed
Support regulatory compliance activities, including manufacturing site registration, audits, post-market vigilance reporting, and product recalls
Provide regulatory support for currently marketed products, including reviewing labeling and changes to existing devices and documentation
Provide feedback and ongoing support to product development teams for regulatory issues and questions
Interact directly with FDA and international regulatory agencies on most projects/products at reviewer level, with significant issues reviewed with the manager
Qualification
Required
Bachelor's degree in a scientific discipline or equivalent with 2 years of relevant experience, or an advanced degree with 0 years of experience
Direct experience in the medical device industry, particularly with Class III medical devices (PMA)
Proven experience preparing and assisting with submitting regulatory filings to the FDA, EU MDR, and other global regulatory agencies
In-depth understanding of FDA requirements, guidance documents, EU MDR, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
Excellent negotiation, written, and oral communication skills to effectively interact with regulatory agencies and cross-functional teams
Strong time management skills, with the ability to multitask, support multiple projects, prioritize, conduct team meetings, and meet project deadlines
Ability to work independently and under general direction only
Proficiency in MS Office, MS Project, Adobe Acrobat, and Agile
Preferred
1-2 years of industry experience, with at least 1-2 years in regulatory, clinical, or quality roles
Advanced degree in a scientific discipline (engineering, physical/biological, or health sciences)
Experience working in a regulated biotechnology environment, including extensive involvement with regulatory submissions and interactions with regulatory agencies
History of successful device submissions
Cybersecurity / Software experience (strong plus)
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
2026-02-04
BioWorld Financial Watch
2026-02-04
2026-02-04
Company data provided by crunchbase