Senior Compliance/Audit Manager

Medtronic

Senior Compliance & Internal Audit Manager at Medtronic leading compliance audits and improving quality systems. Focused on regulatory standards and enterprise-wide risk management.

Posted 7/22/2026full-timeMinneapolis • California, Colorado, Connecticut, Minnesota, Tennessee • 🇺🇸 United StatesSenior💰 $145,600 - $218,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading internal audit activities aligned with global regulatory requirements, including MDSAP and ISO 13485, while effectively managing compliance risks and ensuring organizational preparedness for regulatory inspections.

Highest-signal resume keywords

MDSAP Audit ModelFDA QMSR / 21 CFR Part 820ISO 13485 Quality Management SystemsCertified Lead AuditorRegulatory Compliance Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Internal Audit ManagementRisk-Based Audit PlanningQuality System EvaluationCompliance Risk IdentificationRegulatory Inspection Preparation

Soft Skills

LeadershipCommunicationProblem-Solving

Certifications & Qualifications

Certified Lead Auditor

Industry Keywords

Medical Device IndustryRegulated Healthcare IndustryQuality Management SystemsRegulatory AffairsCompliance Audits

About the role

Key responsibilities & impact

Lead and manage enterprise internal audit activities aligned with global regulatory requirements including MDSAP, QMSR, and ISO 13485.
Develop and execute risk-based audit schedule, audit plans across Medtronic operating units, manufacturing sites, and enterprise functions.
Serve as Lead Auditor for complex or high-impact compliance audits.
Ensure audits are conducted in accordance with internal procedures, regulatory expectations, and recognized auditing standards.
Provide subject matter expertise on regulatory quality requirements and global compliance expectations.
Evaluate the effectiveness and maturity of quality system processes across the organization.
Identify systemic compliance risks and provide recommendations for mitigation.
Support enterprise preparation for regulatory inspections and external audits.
Lead and/or participate in mock inspections and readiness assessments to strengthen organizational preparedness.
Track compliance trends and escalate systemic risks to leadership as appropriate.

Requirements

What you’ll need

Bachelor’s degree plus 7+ years of experience in quality, regulatory affairs, compliance, or related functions in the medical device or regulated healthcare industry.
Minimum 3 years of experience conducting or managing internal or regulatory audits.
Minimum 5 years of managerial experience.
Demonstrated expertise in: MDSAP audit model, FDA QMSR / 21 CFR Part 820, transition to ISO 13485, ISO 13485 Quality Management Systems, Certified Lead Auditor or equivalent auditing certification.
Experience interacting with regulatory agencies or supporting regulatory inspections.

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)