Senior Compliance​/Audit Manager

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

• 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.

Demonstrates expertise in leading internal audit activities aligned with global regulatory requirements, including MDSAP and ISO 13485, while effectively managing compliance risks and ensuring organizational preparedness for regulatory inspections.

• MDSAP Audit Model
• FDA QMSR / 21 CFR Part 820
• ISO 13485 Quality Management Systems
• Certified Lead Auditor
• Regulatory Compliance Management

• Internal Audit Management
• Risk-Based Audit Planning
• Quality System Evaluation
• Compliance Risk Identification
• Regulatory Inspection Preparation

• Leadership
• Communication
• Problem-Solving

• Certified Lead Auditor

• Medical Device Industry
• Regulated Healthcare Industry
• Quality Management Systems
• Regulatory Affairs
• Compliance Audits