Clinical Research Governance Specialist
MasimoIrvine, California, United States
Posted September 26, 2025
69000 - 80000 USD year
Full Time
About the Company
Masimo is a global medical technology company specializing in noninvasive patient monitoring technologies. With over three decades of innovation, Masimo offers clinically-proven products that enhance clinical decision-making and improve patient safety. The company's focus on solving complex medical challenges sets it apart in the industry.
Job Description
The Clinical Research Governance Specialist supports the Clinical Research Compliance function by managing controlled documents, study governance tools, and policy oversight. This role is crucial for maintaining compliance with FDA regulations and ensuring traceability. Responsibilities include leading governance committees, managing clinical trial registrations, reviewing governance deliverables, and supporting audits.
Requirements
- 3+ years experience in a related field.
- Direct, hands-on experience with ClinicalTrials.gov registration and results reporting.
- Knowledge of Good Clinical Practice (ICH E6), FDA regulations (21 CFR Parts 11, 50, 54, 56, 812), and EU MDR 2017/745.
- Strong organizational and documentation management skills.
- Excellent written and oral communication skills.
Benefits
- Potential for annual bonus
- Inclusive culture