Regulatory and Compliance HC Spec 4, Irvine- Irvine Surgical Pathology- FT Day Shift

UCI Health • Orange, CA

249d

About The Position

Reporting to the Regulatory and Compliance Manager, the Regulatory and Quality Assurance Specialist serves as a subject matter expert in Transfusion Medicine, Laboratory and Pathology Medicine regulatory affairs and quality assurance, providing consultative services for department leaders. The specialist is responsible for ensuring compliance with all applicable federal, state, and accreditation regulations governing clinical laboratory and pathology operations. This role supports quality assurance programs, regulatory compliance initiatives, and continuous improvement efforts to maintain the highest standards of patient care and laboratory performance. The specialist collaborates with laboratory leadership, technical staff, and external regulatory agencies to ensure the department meets all regulatory requirements and quality standards.

Requirements

• Ability to maintain a work pace appropriate to the workload.
• Demonstrate customer service skills appropriate to the job.
• Excellent written and verbal communication skills in English.
• Comprehensive understanding of laboratory regulations and accreditation standards (CLIA, CAP, FDA, AABB, Joint Commission, CA DPH etc.).
• Minimum of 5 years of experience in a clinical laboratory setting, with a strong focus on regulatory compliance and quality assurance.
• Bachelor's degree in Medical Laboratory Science, Biological Science, Healthcare Administration, or a related field.
• Ability to design, administer and critically evaluate policies, procedures and processes against regulatory requirements.
• Advanced knowledge and experience/expertise in related field.
• Extensive experience with instrument troubleshooting, repair, testing and verification of system integrity.
• Familiar with Microsoft Office applications.

Nice To Haves

• Master's degree or Certification in Quality or Regulatory Affairs (e.g., ASQ, CQA, RAC).
• Experience in an academic medical center or large hospital laboratory.

Responsibilities

• Ensure compliance with federal, state, and accreditation regulations governing clinical laboratory and pathology operations.
• Support quality assurance programs and regulatory compliance initiatives.
• Collaborate with laboratory leadership and technical staff to maintain high standards of patient care and laboratory performance.
• Provide consultative services for department leaders regarding regulatory affairs and quality assurance.

Benefits

• Medical insurance
• Sick and vacation time
• Retirement savings plans
• Access to discounts and perks

What This Job Offers

• Career Level: Mid Level
• Industry: Hospitals
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees