Medtronic · 5 hours ago
Senior Regulatory Affairs Specialist - CRDN
Mounds View, Minnesota, United States of America
Full-time
Hybrid
Mid, Senior Level
$92K/yr - $138K/yr
4+ years expMedtronic is a global leader in healthcare technology dedicated to solving the most challenging health problems. The Senior Regulatory Affairs Specialist will support Research and Development programs by developing pre-market regulatory strategies for product registration, preparing submissions, and negotiating approvals with global regulatory agencies.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
Responsibilities
Acts as a team member on development projects to provide regulatory guidance and develop global regulatory strategies and timelines for key markets
Author and prepare regulatory submissions for new products and their product changes as required to ensure timely approval for market release. Review significant regulatory issues with manager, as necessary, and resolve submission issues with Medtronic cross functional partners, Medtronic Geography Regulatory partners, and regulatory agencies as needed
Prepare regulatory strategies/plans taking inputs and incorporating worldwide compliance requirements. Provide on-going support to product development teams for regulatory issues and questions. Find, interpret and apply regulations and guidance appropriately for situations
Provide business and product information to enable development of strategies and requirements, as well as communicate that information to the product development teams
Provide regulatory support for currently marketed products as necessary. This includes reviewing labeling and changes to existing devices and documentation. Prepare submissions and reports for regulatory agencies as required
Complete understanding and wide application of technical or regulatory principles, theories and concepts. General knowledge of other related disciplines
Negotiate with regulatory agencies, as needed
Participate in the project team meeting to plan strategies, including reviewing the various specifications and plans/reports, defining target market and distribution method, Medtronic requirements on testing, etc
Work under general supervision following established procedures. Independently determines and develops approach
Keeps current on global directives, regulations harmonized standards and Medtronic procedures and communicates changes that may affect cross functional areas
Provide mentorship, training and support to other junior members of the department
Provide regulatory review and guidance for proposed product claims/labeling and advertising and promotional materials
Participates in inspections/audits either performed internally, by notified bodies, or by other international regulatory bodies
Assist regulatory department in the update, enhancement, and creation of internal policies and procedures
Support assessment and recommendation of new and changing regulations, guidance documents, requirements as needed
Other tasks, as required
Qualification
Required
Bachelor's degree in a technical discipline
Minimum 4 years of medical device regulatory experience
Or minimum 2 years of medical device regulatory experience with an advanced degree
Preferred
Experience working in regulated environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA, Notified Bodies, NMPA and PMDA etc.), and working with cross-functional project teams
Master of Science Degree
In depth experience with FDA requirements, guidance documents, Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
Working with cross functional PDP teams
Direct Regulatory Affairs experience supporting programs throughout software development life cycle
Direct experience authoring and successful approval of regulatory submissions for Class IIb /III/IV medical devices in the US, Japan, or EU (e.g., IDE, PMA, CTN, Shonin, Technical Documentation)
Direct experience supporting successful software device development (SaMD, AI, Cybersecurity, IEC 62304/82304) and associated regulatory filings in the U.S., EU, and globally
Experience with negotiations/interactions with regulatory agencies/health authorities
Experience performing advertising and promotion reviews/approvals for medical devices
Strong negotiation skills and written/oral communication skills
Strong organizational skills and time management skills
Ability to support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
Ability to work independently and under general direction only
Computer skills; MS Office, MS Project, Adobe Acrobat and Agile
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
BioWorld Financial Watch
2026-01-25
Company data provided by crunchbase