Principal Regulatory Strategy Specialist

Medtronic

Principal Regulatory Strategy Specialist at Medtronic providing regulatory strategies for medical devices and innovative technologies. Collaborating with teams on complex regulatory questions and supporting M&A activities.

Posted 6/4/2026full-timeColorado, Connecticut, Minnesota • 🇺🇸 United StatesSeniorLead💰 $120,000 - $180,000 per yearWebsite

About the role

Key responsibilities & impact

Partner with operating unit regulatory teams to help develop and refine strategies for complex medical devices, novel technologies, significant product changes, and market expansion opportunities.
Provide strategic input on regulatory pathways, intended use, claims, evidence expectations, risk management, and post-market commitments.
Support regulatory authority interactions by helping frame key questions, review briefing materials, contribute to response strategies, and communicate positions clearly and credibly.
Advise on software and digital-health regulatory strategy, including software lifecycle expectations, AI-enabled functionality, interoperability, and connected systems.
Serve as an enterprise advisor to operating unit regulatory teams conducting M&A, integration, or remediation activities by helping identify potential regulatory opportunities, risks, relevant internal process considerations, and applicable cross-portfolio precedent.
Translate regulatory intelligence regarding evolving global regulations, guidance, policy, and deficiency trends into practical implications for Medtronic business regulatory strategies.
Identify recurring strategic issues and deficiency trends across operating units to inform training content.
Synthesize complex technical and regulatory issues into clear recommendations for senior leaders, regulatory teams, and cross-functional partners.

Requirements

What you’ll need

Minimum of 7 years of experience within the medical device industry or a regulatory agency with a bachelor's degree or a master’s degree with a minimum of 5 years of relevant experience.
Experience developing or advising on global regulatory strategies, pathways, and evidence approaches for complex, high-risk, or novel technologies.
Experience supporting medical device submissions and health authority interactions.
Working knowledge of software and AI-enabled medical devices, including software lifecycle management, documentation, risk management, validation, maintenance, and change control.
Experience providing regulatory input to teams involved in mergers, acquisitions, licensing, or integration activities.
Direct experience working for a regulator, particularly in a scientific review role.
Demonstrated ability to translate changing regulatory expectations into practical internal guidance or educational content.
Strong analytical judgment, with the ability to balance business objectives, regulatory requirements, patient impact, and execution risk.
Strong collaboration and influence skills, with the ability to build trust across businesses, functions, and geographies.
Knowledge of product development, clinical strategy, quality systems, manufacturing, and post-market requirements for medical devices.
Advanced degree in a technical, scientific, or engineering area RAC certification or similar credential is a plus.

Benefits

Comp & perks

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)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory strategiesmedical device submissionssoftware lifecycle managementrisk managementvalidationchange controlevidence approachesAI-enabled medical devicesclinical strategyquality systems

Soft Skills

analytical judgmentcollaborationinfluencetrust buildingcommunicationstrategic inputsynthesis of complex issuestraining content developmentproblem-solvingcross-functional partnership

Certifications

RAC certification