Clinical Complaint Specialist (Medical Devices)

Location: On-site in Irvine, California, United States

Salary: $80,000–$100,000 annual base salary, plus target bonus/incentive pay of 10% of annual base salary

Company

Masimo is a hirify.global operating company that develops medical monitoring technologies, sensors, patient monitors, and healthcare connectivity solutions.

What you will do

• Review, evaluate, and process medical device complaints under applicable regulations, company procedures, and quality system requirements.
• Perform clinical assessments to determine complaint severity, potential patient impact, and device-relatedness.
• Evaluate complaints for regulatory reportability, including Medical Device Reporting, vigilance reporting, and other global adverse event requirements.
• Support complaint investigations and maintain accurate complaint documentation.

Requirements

• 3+ years of clinical nursing or direct patient care experience.
• Registered Nurse, Bachelor of Science in Nursing, or equivalent clinical degree.
• Ability to interpret medical records, clinical documentation, and adverse event information.
• Ability to work on-site in Irvine, California, United States.

Nice to have

• Experience in the medical device, biotechnology, pharmaceutical, diagnostics, or healthcare industry.
• Experience with complaint handling, adverse event reporting, post-market surveillance, or quality systems.
• Knowledge of FDA Medical Device Reporting requirements, complaint handling requirements, and international vigilance regulations.

Culture & Benefits

• Paid time off.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) benefits for eligible employees.
• Eligibility for bonus or incentive pay.
• Work within a quality compliance team focused on product safety and regulatory compliance.