Principal Compliance/Audit Specialist (Medical Devices)

Location: On-site in Northridge, California, United States; requires a minimum of 4 days per week in Northridge, CA.

Salary: $121,000–$205,000 USD for California-based roles.

Company

hirify.global develops insulin delivery systems, predictive insights, and support solutions for people living with diabetes.

What you will do

• Coordinate and complete internal and external risk assessments, audits, and compliance activities against US and international regulatory requirements.
• Manage internal audits, investigations, interviews, reports, and supporting documentation.
• Interpret and implement regulations for products, processes, practices, and procedures, and advise stakeholders on compliance requirements.
• Investigate and resolve compliance violations, questions, and concerns involving internal and external regulatory requirements.
• Analyze audit data, present findings to management and regulatory bodies, and support Corrective Action Plans, including coaching business partners on corrective actions.
• Develop compliance programs, communications, and training to improve employee awareness of compliance policies and processes.

Requirements

• Bachelor’s degree with 7+ years of relevant experience, or an advanced degree with 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 have

• Knowledge and practical application of medical-device risk management, including risk analyses, risk controls, residual risk, risk-benefit determinations, risk-management files, and objective evidence.
• Ability to analyze complex data, communicate findings to leadership, collaborate, influence stakeholders, and manage stakeholder relationships.
• 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, including IEC 81001-5-1, FDA cybersecurity expectations, threat modeling, or vulnerability management.
• Experience with IEC 62304 software lifecycle processes and IEC 62366 usability engineering.

Culture & Benefits

• Mission-driven work supporting people living with diabetes through insulin delivery and related technologies.
• Health, dental, and vision insurance, plus Health Savings Account and Healthcare Flexible Spending Account access.
• Life insurance, short- and long-term disability coverage, paid time off, and paid holidays.
• 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Program, and additional eligible retirement benefits.
• Regular employees working 20 or more hours per week are eligible for the benefits package.