Senior Compliance/Audit Manager

About the role

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 role partners 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.

Responsibilities

• 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.
• Partner with site leadership to address compliance gaps and ensure sustainable remediation.
• 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.
• 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.
• 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.
• Mentor and develop internal auditors and cross-functional audit team members.
• Provide training and coaching on regulatory audit techniques and compliance practices.

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

• 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.

Physical Job Requirements

While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.

Travel Requirements

Able to travel domestically and internationally up to 10–20% to Medtronic sites.

Benefits & Compensation

Salary ranges for U.S. (excl. PR) locations (USD): $145,600.00 - $218,400.00. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).