Regulatory Affairs & Quality Assurance Manager

🇺🇸 Orange, CA 🕑 Full-Time 💰 $97K - $182K 💻 Quality Assurance 🗓️ May 23rd, 2026

IRB Rive

Edtech.com's Summary

University of California, Irvine is hiring a Regulatory Affairs & Quality Assurance Manager. This role directs all regulatory and quality assurance operations for clinical research at the UCI Center for Clinical Research, overseeing teams responsible for regulatory compliance, quality improvement, and clinical trial management to ensure audit-ready operations and strategic initiative implementation.

Highlights

Manage regulatory affairs and quality assurance operational matters within clinical research under UC Irvine Health.
Directly supervise Regulatory Affairs and Quality Assurance supervisors and their teams.
Lead workforce planning, operational strategy, continuous quality improvement, and HR-related functions.
Ensure compliance with FDA regulations, GCP, ICH guidelines, HIPAA, and manage relationships with IRB, FDA, and institutional bodies.
Require knowledge of OnCore Clinical Trials Management System, Microsoft Office Suite, and clinical protocol design.
Minimum 5-7 years of regulatory oversight and/or quality assurance experience in academic or clinical research settings with a bachelor's degree or equivalent.
Certification as a Clinical Trial Professional expected within one year of employment.
Preferred experience includes knowledge of research billing, budget management, FDA inspection process, and an advanced degree.
Salary range from $97,000 to $182,200 per year, with additional comprehensive benefits.
Job requires occasional after-hours work and travel between UCI campuses.