Regulatory Affairs Specialist (Medical Devices)

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

Annual salary: $80,000–$100,000, plus a target bonus of 10% of annual base salary.

Company

Masimo is a hirify.global operating company developing medical technology such as monitoring technologies, sensors, patient monitors, and connectivity solutions.

What you will do

• Manage domestic and international regulatory filings and product registrations.
• Draft and compile 510(k) Premarket Notifications, technical files, STED documents, and related submissions.
• Coordinate with regional regulatory teams on product changes and notification or approval requirements.
• Support communications with regional representatives, health authorities, and notified bodies worldwide.
• Provide regulatory assessments of medical device regulations to support future products and pre-market clearances.

Requirements

• 2+ years of experience in a Class II/III medical device environment.
• Bachelor’s degree required, preferably in Engineering or Life Sciences.
• Excellent documentation, record-maintenance, tracking, and document-traceability skills.
• Ability to work on-site in Irvine, California.

Nice to have

• Experience with FDA Class II medical device submissions and equivalent international classification requirements.
• Knowledge of FDA/GMP requirements for medical devices.
• Experience with quality systems based on ISO 13485.
• Graduate degree.

Culture & Benefits

• Work within a regulatory affairs team supporting medical technology that contributes to patient care.
• Paid time off.
• Medical, dental, and vision insurance.
• 401(k) plan for eligible employees.
• Bonus and incentive eligibility.