Senior Compliance/Audit Manager
$145,600–$218,400 year
On-siteIrvine, California, United States or Memphis, Tennessee, United States
Job Summary
Lead and manage enterprise internal audit activities aligned with global regulatory requirements including MDSAP, QMSR, and ISO 13485. Develop and execute risk-based audit schedules across operating units, manufacturing sites, and enterprise functions, serving as Lead Auditor for complex compliance audits. Provide subject matter expertise to evaluate quality system processes, identify systemic risks, and support inspection readiness through mock inspections and readiness assessments. Review audit findings, ensure root cause analysis, and monitor corrective action effectiveness while collaborating with global stakeholders to drive continuous improvement. Minimum 7 years of experience in medical device quality or regulatory affairs required, with 3 years managing internal audits. Minimum 4 days a week onsite travel expected.
Required 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
- Demonstrated expertise in FDA QMSR / 21 CFR Part 820 transition to ISO 13485
- Demonstrated expertise in ISO 13485 Quality Management Systems
- Certified Lead Auditor or equivalent auditing certification
- Experience interacting with regulatory agencies or supporting regulatory inspections
- Ability to travel domestically and internationally up to 10–20% to Medtronic sites
- For Office Roles: While performing the duties of the job, the employee is regularly required to be independently mobile
- For Office Roles: The employee is also required to interact with a computer, and communicate with peers and co-workers
- U.S. work authorization at the time of hire and for the duration of employment
Desired 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
- 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
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