Principal Compliance/Audit Specialist
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Before you apply
LocationNorthridge, California, United States of America
Work modeon-site
Typefull-time
SeniorityLead
Experience5+ yrs
Company size10,000+ people
PostedOct 2, 2026 · 1mo ago
Verified live3d ago
At a glanceSummarised by Seekless from the posting.
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)
We anticipate the application window for this opening will close on - 30 Oct 2026
About the company
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.
Responsibilities
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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.
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Manages and oversees internal audit activities, which may include conducting and/or overseeing audits, investigations, and/or interviews; and preparing corresponding reports and documents.
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Interprets and implements applicable regulations as they apply to products, processes, practices and procedures.
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May counsel stakeholders about these requirements as necessary.
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Ensures compliance with internal and external regulatory agencies, which may include investigating and resolving compliance violations, questions, or concerns.
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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.
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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.
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Bachelor’s degree with 7+ years’ relevant experience, or Advanced degree with 5 years of experience.
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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)