Principal Compliance/Audit Specialist

MiniMed•Los Angeles, CA

2d•$121,000 - $205,000•Onsite

About The Position

The Principal Compliance/Audit Specialist leads audits, compliance assessments, and risk evaluations to strengthen audit readiness and quality system effectiveness in a regulated medical-device environment. The role partners with cross-functional teams to identify and address gaps, implement corrective actions, and provide expert guidance on regulatory requirements. The position is on-site in Northridge, California, and requires at least four days per week on site. The specialist coordinates and/or completes internal and external risk assessments, audits, and compliance activities in accordance with applicable regulatory standards. The role manages internal audit activities, interprets and implements regulations, supports compliance investigations and resolutions, analyzes audit findings, and helps business partners develop and implement corrective actions. It also develops programs, communications, and training to increase employee awareness of compliance policies and processes.

Requirements

Bachelor’s degree and at least 7 years of relevant experience, or an advanced degree and at least 5 years of experience.
Experience in medical-device quality and regulatory compliance, with 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, such as ASQ CQA, ISO 13485 Lead Auditor, or equivalent.

Nice To Haves

Demonstrated knowledge and practical application of medical-device risk-management principles, including evaluating risk-management processes, risk analyses, risk controls, residual risk, risk-benefit determinations, and risk-management files; challenging risk-based decisions; and assessing whether changes are appropriately evaluated and supported by objective evidence.
Ability to analyze complex data and communicate findings to leadership, with 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.
Medical-device cybersecurity experience, 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.

Responsibilities

Coordinate and/or complete internal and external risk assessments, audits, and compliance activities in accordance with applicable regulatory standards.
Manage and oversee internal audit activities, including conducting or overseeing audits, investigations, and interviews, and preparing related reports and documents.
Interpret and implement applicable regulations as they apply to products, processes, practices, and procedures.
Counsel stakeholders on regulatory requirements as necessary.
Ensure compliance with internal and external regulatory agencies, including investigating and resolving compliance violations, questions, or concerns.
Analyze audit data and present findings to management and/or regulatory bodies in support of Corrective Action Plans.
Coach business partners on compliance gaps, data, and resulting corrective actions.
Develop and implement programs, communications, and training to increase employee awareness and knowledge of compliance policies and processes.

Benefits

Competitive salary and flexible benefits package.
Health, dental, and vision insurance.
Health Savings Account and Healthcare Flexible Spending Account.
Life insurance and long-term disability leave.
Dependent daycare spending account.
Incentive plans.
401(k) plan with company match.
Short-term disability coverage.
Paid time off and holidays.
Employee Stock Purchase Plan.
Employee Assistance Program.
Eligible employees may have access to a Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements.