Principal Compliance/Audit Specialist

MiniMed Group; California, Northern (MO, KY); Híbrido; USD 121 000 - 205 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Competitive salary

Full benefits package

Resumo da oferta

MiniMed is seeking a Principal Compliance/Audit Specialist to strengthen compliance, audit readiness, and quality system effectiveness within a regulated medical device environment.

You will lead audits, risk evaluations, and CAPA, partnering with cross-functional teams to address gaps and implement corrective actions while guiding on regulatory requirements. On-site role with 4 days/week in Northridge, CA.

Qualificações

• 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.

Responsabilidades

• Lead internal/external audits and risk assessments in a regulated medical device environment.
• Interpret and implement applicable regulations for products, processes, and QMS.
• Provide guidance on regulatory requirements and drive corrective actions.
• Develop training and awareness programs to improve compliance knowledge.
• Support regulatory inspections and readiness initiatives.

Conhecimentos

Auditing

Regulatory compliance

FDA knowledge

ISO 13485

CAPA effectiveness

Risk assessments

Stakeholder management

Regulatory inspections

Cybersecurity (medical devices)

IEC 62304

IEC 62366 usability

Formação académica

Bachelor's degree

Advanced degree

Descrição da oferta de emprego

* You may choose to display a cookie banner on the external site. You must specify the message in the cookie banner and may add a link to a relevant policy. If you are unfamiliar with these requirements, please seek the advice of legal counsel.* .Principal Compliance/Audit Specialist page is loaded## Principal Compliance/Audit Specialistremote type: On-Sitelocations: Northridge, California, United States of Americatime type: Full timeposted on: Posted Yesterdaytime left to apply: End Date: October 16, 2026 (12 days left to apply)job requisition id: R-801976We anticipate the application window for this opening will close on - 16 Oct 2026At 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**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*****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 81001-5-1FDA cybersecurity expectations, threat modeling, or vulnerability management.* Experience with IEC 62304 software lifecycle processes.* Experience with IEC 62366 usability engineering.#BetterDaysStartNow# **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 - $185,000.00For 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).At MiniMed, we are committed to supporting the well-being and financial security of our employees. 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.Overview# **About MiniMed**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