at Medtronic
Location
5 Locations
Compensation
$146k–$218k USD
Posted
5 days ago
Market range · company + function + seniority
p25 · target · p75 · n=20
Posted $218k · well above market
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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 95,000 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.
Business Group: Global Quality / Enterprise Quality
Location: Flexible (U.S. or Global Medtronic Location)
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.
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 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.
Regulatory Compliance & Risk Oversight
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.
Inspection and Audit Readiness
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.
Corrective Action & Compliance Monitoring
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.
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 leadership as per defined intervals and in management reviews.
Provide guidance on interpretation of regulatory requirements and quality system expectations.
Continuous Improvement
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.
Leadership & Talent Development
Mentor and develop internal auditors and cross‑functional audit team members.
Provide training and coaching on regulatory audit techniques and compliance practices.
Minimum 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
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
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.
Leadership Competencies (Medtronic Leadership Expectations)
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.
Travel Requirements
Ability to travel domestically and internationally up to 10–20% 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 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.
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 @medtronic.com 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 AskHR@medtronic.com.
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.
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 insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple 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 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), and Capital 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 law. In 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 find here 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.
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