Principal Compliance/Audit Specialist

USA-Medtronic MiniMed, Inc 1017; Los Angeles (CA); On-site; USD 121,000 - 205,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

401(k) plan with company match

Paid time off and holidays

Job summary

MiniMed in Northridge, CA is seeking a Principal Compliance/Audit Specialist to lead audits, assessments, and risk evaluations in a regulated medical device environment. You will partner with cross-functional teams to address gaps and implement corrective actions, guiding regulatory requirements across the organization.

The ideal candidate has strong auditing, regulatory, and stakeholder-management skills, with a passion for continuous improvement and patient safety.

Qualifications

• Bachelor’s degree with 7+ years’ relevant experience, or Advanced degree with 5 years.
• Experience in medical device quality and regulatory compliance; strong knowledge of FDA, ISO 13485.
• Experience in auditing, risk assessment, and CAPA effectiveness.
• Experience supporting regulatory inspections and driving inspection readiness.
• Certified Auditor certification (ASQ CQA, ISO 13485 Lead Auditor, or equivalent).

Responsibilities

• Lead audits, compliance assessments, and risk evaluations.
• Partner with cross-functional teams to address gaps and implement corrective actions.
• Provide expert guidance on regulatory requirements.
• Counsel stakeholders about regulatory requirements as necessary.
• Ensure compliance with internal and external regulatory agencies and manage violations.

Skills

Auditing

Regulatory compliance

Risk assessment

CAPA effectiveness

Regulatory inspections

Stakeholder management

Education

Bachelor’s degree with 7+ years’ relevant experience

Advanced degree with 5 years’ experience

Certified Auditor certification (ASQ CQA, ISO 13485 Lead Auditor, or equivalent)

Tools

ASQ CQA

Job description

We anticipate the application window for this opening will close on - 30 Oct 2026

At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.

About the Role

Are you passionate about driving compliance excellence and strengthening audit readiness within a highly regulated medical device environment? Join MiniMed as a Principal Compliance/Audit Specialist and play a key role in strengthening compliance, audit readiness, and quality system effectiveness within a regulated medical device environment.

In this role, you will lead audits, compliance assessments, and risk evaluations; partner with cross-functional teams to address gaps and implement corrective actions; and provide expert guidance on regulatory requirements.

The ideal candidate is an experienced compliance professional with strong auditing, regulatory, and stakeholder management skills who is passionate about driving continuous improvement and protecting patient safety.

On-site role requiring minimum 4 days per week in Northridge, CA.

Coordinates and/or completes internal/external risk assessments and/or audits and compliance in accordance with regulatory standards, which may include US and/or international regulatory agencies / authorities.

Manages and oversees internal audit activities, which may include conducting and/or overseeing audits, investigations, and/or interviews; and preparing corresponding reports and documents.

Interprets and implements applicable regulations as they apply to products, processes, practices and procedures.

May counsel stakeholders about these requirements as necessary.

Ensures compliance with internal and external regulatory agencies, which may include investigating and resolving compliance violations, questions, or concerns.

Analyzes audit data and presents findings to management and/or regulatory bodies in support of Corrective Action Plans, which may include coaching business partners on compliance gaps, data, and/or resulting corrective actions.

Develop and implement programs, communications, and/or training designed to increase employee awareness and knowledge of compliance policies and/or processes.

Must Have: Minimum Requirements

• Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident on your resume.
• Bachelor’s degree with 7+ years’ relevant experience, or Advanced degree with 5 years of experience.
• Experience in medical device quality and regulatory compliance; strong knowledge of FDA, ISO 13485, and other applicable regulatory requirements.
• Experience in auditing, risk assessment, and CAPA effectiveness.
• Experience supporting regulatory inspections and driving inspection readiness initiatives.
• Certified Auditor certification (ASQ CQA, ISO 13485 Lead Auditor, or equivalent).

Nice To Have

• Risk management: Demonstrated knowledge and practical application of medical-device risk management principles, including the ability to evaluate risk-management processes, risk analyses, risk controls, residual risk, risk-benefit determinations, and risk-management files; challenge the adequacy and consistency of risk-based decisions; and assess whether changes to products, processes, suppliers, or the QMS have been appropriately evaluated for risk and supported by objective evidence.
• Ability to analyze complex data and communicate findings to leadership; and strong collaboration, influencing, and stakeholder management skills.
• Familiarity with global medical device regulations and standards, including EU MDR and international compliance requirements.
• Experience developing compliance training, awareness programs, and quality culture initiatives.
• Cybersecurity experience involving medical devices, such as IEC 81001-5-1 FDA cybersecurity expectations, threat modeling, or vulnerability management.
• Experience with IEC 62304 software lifecycle processes.
• Experience with IEC 62366 usability engineering.

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.

Benefits & Compensation

• MiniMed offers a competitive salary and flexible benefits package
• At MiniMed, we put people first.
• A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create.
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.
• Salary ranges for U.S (excl. PR) locations (USD):$109,000.00 - $185,000.00
• For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $121,000 - $205,000 USD.
• Actual compensation may vary based on factors including experience, education, certifications, skills, market conditions, internal equity, and geographic location.
• Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
• Regular employees working 20 or more hours per week are eligible for a robust benefits package, including health, dental, and vision insurance, as well as access to a Health Savings Account, Healthcare Flexible Spending Account, life insurance, long-term disability leave, and a dependent daycare spending account.
• In addition, all regular employees enjoy incentive plans, a 401(k) plan with company match, short-term disability coverage, paid time off and holidays, participation in our Employee Stock Purchase Plan, and access to our Employee Assistance Program.
• Eligible employees may also benefit from our Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements.
• Please note that “regular employees” refers to those who are not temporary staff, such as interns, and some benefits may not apply to employees in Puerto Rico.
• For further details about our comprehensive benefits, we encourage you to visit the link below.

MiniMed Benefits Overview

MiniMed is a full-stack insulin delivery company dedicated to supporting people living with diabetes through every step of their journey — when and how they need it. For more than 40 years, we’ve been committed to redefining what’s possible: intelligent dosing systems designed for real life, predictive insights that stay a step ahead, and always on support when it’s needed most. At the heart of everything we do is a simple Mission: to make every day a better day for people with diabetes. Learn more about our business, and our mission here.

It is the policy of MiniMed 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, familial status, membership or activity in a local human rights commission, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state, or local law. In addition, MiniMed will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for MiniMed 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 MiniMed reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. MiniMed 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.

MiniMed is a full-stack insulin delivery company dedicated to supporting people living with diabetes through every step of their journey — when and how they need it. With a heritage rooted in technology, empathy, and a relentless pursuit of innovation, we’re focused on one thing: making every day a better day for people with diabetes. From our intelligent dosing systems that stay one step ahead to our always-on support when it’s needed most, we’re committed to building a connected system of care that works together and fits into everyday life, so people with diabetes can move through the day with fewer interruptions. Fewer second guesses. And more freedom to live in the moment. We’re here to make better days possible for people with diabetes. Joyful, messy, fully lived days. Days where things feel lighter, easier. For more than four decades, we’ve been driven by this mission, delivering groundbreaking advancements in technology to help people live more fully, freely, and with greater confidence. At MiniMed, diabetes care is personal for us. Many of our employees have a connection to diabetes, whether they’re living with it themselves or through family members and friends, and we all show up each day to help make the lives of our coworkers and loved ones easier. Our people-first priority. At MiniMed, we put our customers at the forefront of all we do, and that focus extends to our team as well. We're dedicated to creating a culture of belonging and providing our people with all the career-building resources you might need. Our life-transforming technologies. No matter what your role at our company, you're making a difference in the lives of people with diabetes. Our innovative inventions improve their day-to-day by helping lift the mental load and allowing diabetes to fade into the background, empowering them to live life on their own terms. Our focus on the future. We're chasing the dream of a world where people with diabetes can be free of that never-ending battle of balancing blood sugar. A world where better days are the norm, not the exception. Fresh faces and new viewpoints will help create our cutting-edge solutions and define the next generation of breakthroughs in care, so that a better day can start today.

It is the policy of MiniMed 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, MiniMed will provide reasonable accommodations for qualified individuals with disabilities.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees.

Thank you for reviewing this posting. You may now search for other opportunities at MiniMed that match your skills and experience.