Senior Compliance/Audit Manager

About this role

We anticipate the application window for this opening will close on - 18 Aug 2026   Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life                     Business Group: Global Quality / Enterprise Quality   Location: Flexible (U.S. or Global Medtronic Location)  

The Senior Manager, Compliance & Internal Audit   is responsible for   leading and advancing Medtronic’s global   internal   audit program to ensure compliance with applicable regulatory requirements and quality management standards. This role provides strategic leadership for internal audits aligned with the Medical Device Single Audit Program (MDSAP), FDA Quality Management System Regulation (QMSR), ISO 13485, and other applicable global regulatory frameworks.  

The Senior Manager will partner   cross ‑ functionally   with Quality, Regulatory Affairs, Operations, R&D, and functional leadership to assess enterprise compliance,   identify   systemic risks, and strengthen the effectiveness of the Medtronic Quality Management System. This role plays a key   part   in driving inspection readiness and supporting continuous improvement across the enterprise.  

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. 

Key Responsibilities  

Internal Audit Program Leadership  

• 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.  

Regulatory Compliance & Risk Oversight  

• 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.  

Inspection and Audit Readiness  

• Support enterprise preparation for regulatory inspections and external audits.  

• Lead   and/or   participate   in   mock inspections and readiness assessments to strengthen organizational preparedness.  

• Partner with site leadership to address compliance gaps and ensure sustainable remediation.  

Corrective Action & Compliance Monitoring  

• Review audit findings and ensure   appropriate root   cause analysis and corrective actions.  

• Monitor effectiveness of CAPA activities related to   internal   audit observations.  

• Track compliance trends and escalate systemic risks to leadership as   appropriate .  

Stakeholder Engagement  

• Collaborate with global stakeholders including Quality, Regulatory Affairs, Manufacturing, Supply Chain, and R&D.  

• Communicate audit results, risk assessments, and improvement opportunities to senior leadership   as per defined intervals and   in management reviews .  

• Provide guidance on interpretation of regulatory requirements and quality system expectations.  

Continuous Improvement  

• Identify   enterprise trends and opportunities for quality system improvement based on audit data.  

• Enhance audit methodologies, tools, and analytics capabilities.  

• Contribute to strengthening a proactive culture of compliance and quality.  

Leadership & Talent Development  

• Mentor and develop internal auditors and   cross ‑ functional   audit team members.  

• Provide training and coaching on regulatory audit techniques and compliance practices.  

Minimum Qualifications

• 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.  

Preferred Qualifications  

• Bachelor’s degree in engineering, Life Sciences, Quality, Regulatory Affairs, or related field.   Advanced degree (MS, MBA, or related field).  

• Experience with global regulatory frameworks including EU MDR, Health Canada, PMDA, TGA, and ANVISA.  

• MDSAP auditing experience.  

• ASQ certifications (CQA, CQE, or equivalent).  

• Experience leading   enterprise ‑ level   compliance or audit programs.  

Leadership Competencies (Medtronic Leadership Expectations)  

• Strategic mindset with the ability to assess   enterprise ‑ level   compliance risks.  

• Strong stakeholder engagement and influencing skills across global organizations.  

• Ability to translate regulatory requirements into practical operational improvements.  

• Data ‑ driven   decision making and risk management.  

• Commitment to developing talent and building strong audit capabilities.  

Travel Requirements

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