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.

- 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.

- 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.

- 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.

- Ability to travel domestically and internationally up to 10 - 2 0% to Medtronic s ites .

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

The 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.

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs.

Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.