Medtronic · 2 days ago
Prin Regulatory Affairs Spec
Lafayette, Colorado, United States of America
Full-time
Onsite
Senior Level, Lead/Staff
$118K/yr - $178K/yr
5+ years expMedtronic is a leader in global healthcare technology, committed to alleviating pain, restoring health, and extending life. The Principal Regulatory Affairs Specialist will be responsible for executing regulatory activities related to the Bispectral Index™ monitoring product portfolio, collaborating with cross-functional teams to ensure regulatory compliance throughout product development and lifecycle management.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
Responsibilities
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections
Leads and compiles all materials required for US and EU submissions and tenders, including 510(k) submissions, NB sampling, and EU MDR Technical Documentation
Supports submissions and inquiries for global markets
Collaborates closely with cross-functional partners such as R&D, clinical, operations, and marketing to establish regulatory value and ensure regulatory requirements and strategy are integrated into product development and lifecycle management
Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance
Reviews promotional material
Monitors, updates, and improves project tracking and US/EU distribution control systems
Proactively monitor and interpret evolving global regulatory requirements and communicate potential impact to stakeholders
May direct interaction with regulatory agencies on defined matters
Recommends strategies for earliest possible path to market
Support internal and external audits/inspections, including serving as a functional lead
Develop and deliver training on regulatory requirements and changes to cross-functional teams
Mentor junior regulatory staff or provide onboarding support
Participate in CAPA investigations when regulatory issues are identified
Qualification
Required
Bachelor's degree required
Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience
Experience in medical device regulatory
Strong experience with class I and II electrical and software-based devices including applicable standards
Strong knowledge of EU MDR, ISO 10993- 1, 13485, and ISO risk management principles
Experience with regulatory requirements for cybersecurity, AI, and communication devices (interoperability)
Proven experience authoring and leading 510(k) submissions and EU Change Notifications
Strong experience compiling MDR Technical Documentation
Experience communicating directly with regulators
Collaborative, solution-oriented performer focused on bringing value to stakeholders and the organization
Proven ability to develop and execute robust regulatory strategies
Strong experience reviewing promotional materials for US/EU markets
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
2026-01-09
Beyond Bylines
2026-01-09
2026-01-08
Company data provided by crunchbase