Senior Compliance/Audit Manager
About The Position
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.
Requirements
- 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.
Nice To Haves
- 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.
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.
- 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.
- 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.
Benefits
- 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)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
