We anticipate the application window for this opening will close on - 21 Jul 2026
A Day in the LifeBusiness 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 ResponsibilitiesInternal 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:
- 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 - Ability to travel domestically and internationally up to 10-20% to Medtronic sites.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. a7 214.2(h)(4)(iii)(A) is required.
Physical Job RequirementsThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
