Senior ComplianceAudit Manager

Medtronic


Job Location:

Minneapolis, MN - USA

Monthly Salary: $ 145600 - 218400
Posted on: 7 days ago
Vacancies: 1 Vacancy

Job Summary

We anticipate the application window for this opening will close on - 21 Jul 2026


Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain restore health and extend life. Our 95000 employees work across more than 150 countries to put patients first developing innovative medical technologies that improve the lives of 72 million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose growth and impact.

A Day in the Life

Business Group: Global Quality / Enterprise Quality
Location: Flexible (U.S. or Global Medtronic Location)

The Senior Manager Compliance & Internal Auditis responsible forleading and advancing Medtronics globalinternalaudit 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 partnercrossfunctionallywith Quality Regulatory Affairs Operations R&D and functional leadership to assess enterprise complianceidentifysystemic risks and strengthen the effectiveness of the Medtronic Quality Management System. This role plays a keypartin 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 -person exchanges are invaluable to our work. Were 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 Responsibilities

Internal Audit Program Leadership

  • Lead and manage enterprise internal audit activities aligned with global regulatory requirements including MDSAP QMSR and ISO 13485.

  • Develop and executeriskbasedauditschedule auditplans across Medtronic operating units manufacturing sites andenterprisefunctions.

  • Serve as Lead Auditor for complex orhighimpactcompliance audits.

  • Ensure audits are conductedin accordance withinternal procedures regulatory expectations and recognized auditing standards.

Regulatory Compliance & Risk Oversight

  • Provide subject matterexpertiseon 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.

  • Leadand/orparticipateinmock 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 ensureappropriate rootcause analysis and corrective actions.

  • Monitor effectiveness of CAPA activities related tointernalaudit observations.

  • Track compliance trends and escalate systemic risks to leadership asappropriate.

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 leadershipas per defined intervals andin management reviews.

  • Provide guidance on interpretation of regulatory requirements and quality system expectations.

Continuous Improvement

  • Identifyenterprise 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 andcrossfunctionalaudit team members.

  • Provide training and coaching on regulatory audit techniques and compliance practices.

Minimum Qualifications

  • Bachelors degree plus 7 years of experience in quality regulatory affairs compliance or related functions in the medical device or regulated healthcare industry.

  • Minimum3years of experience conducting or managing internal or regulatory audits.

  • Minimum 5 years ofmanagerialexperience

  • Demonstratedexpertisein:

  • 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.

Preferred Qualifications

  • Bachelors 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 leadingenterpriselevelcompliance or audit programs.

Leadership Competencies (Medtronic Leadership Expectations)

  • Strategic mindset with the ability to assessenterpriselevelcompliance risks.

  • Strong stakeholder engagement and influencing skills across global organizations.

  • Ability to translate regulatory requirements into practical operational improvements.

  • Datadrivendecision making and risk management.

  • Commitment to developing talent and building strong audit capabilities.

Travel Requirements

  • Ability to traveldomestically andinternationally up to1020% to Medtronic sites.

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.

Physical Job Requirements

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.

U.S. Work Authorization & Sponsorship

At Medtronic we are committed to fostering an environment where employees can thrive and make a meaningful 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.

Recruitment Fraud Alert

We are aware of phishing scams targeting job seekers. Please keep the following in mind:


Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @ email addresses.


Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.


If you receive a suspicious message claiming to be from Medtronic do not respond click links or open attachments.


If you have any questions concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic please contact us immediately at .

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$145600.00 - $218400.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience certification/education market conditions and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).

Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.


If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.


Required Experience:

Manager

We anticipate the application window for this opening will close on - 21 Jul 2026Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain restore health and extend life. Our 95000 employees work across more than 150 countries to put...

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About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an excit ... View more

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