Pangea Laboratory · 23 hours ago
Quality Assurance and Regulatory Specialist
Tustin , CA
Full-time
Onsite
Entry, Mid Level
$70K/yr - $85K/yr
2+ years expPangea Laboratory is a California-based diagnostics company focused on the precise, early detection of emerging diseases. The Quality Assurance & Regulatory Specialist ensures that products, processes, and documentation meet required quality standards and comply with relevant regulatory frameworks while supporting product approval and patient safety.
BiotechnologyHealth CareHealth DiagnosticsMedical
Responsibilities
Develop, implement, and maintain quality management systems (QMS)
Conduct or coordinate internal audits, supplier audits to ensure compliance with regulatory standards (e.g., CLIA, CAP)
Oversee document control, change control, CAPA (Corrective and Preventive Actions), nonconformance management, complaint handling, and Medical Device Reporting (MDR)/Vigilance
Coordinate proficiency testing programs and analyze results to identify areas for improvement
Ensure all regulatory licenses are up to date
Maintain quality documentation, SOPs, and testing procedures
Prepare and present quality metrics and reports for management review
Train and provide orientation to all new hire personnel; review all associated training documents; and monitor the competency process of testing personnel
Be familiar with laboratory protocols and procedures for specimen processing, operating equipment and instruments, maintenance of designated laboratory environment and instruments, and data analysis
Review and approve product labeling, packaging, promotional materials, and technical documentation for regulatory compliance
Monitor changes in global regulations, standards, and guidelines; assess impact on company processes and recommend updates
Collaborate with cross-functional teams (R&D, manufacturing, engineering, clinical, marketing) to ensure regulatory and quality requirements are integrated early in product development
Lead or support management reviews, training programs on regulatory/quality topics, and continuous improvement initiatives
Prepare, submit, and maintain regulatory documents, filings, and reports
Coordinate with regulatory bodies for product approvals and certifications
Monitor regulatory changes and update internal processes accordingly
Follow Pangea Laboratory health and safety policies and procedures and are responsible for reporting violations and enforcing these policies and procedures
Participate as an external auditor for the Pangea Laboratory College of American Pathologist inspection team as required by the College of American Pathologists accreditation program
Qualification
Required
A minimum of 2 to 3 years' laboratory experience
Strong knowledge of key regulations and standards: CAP/CLIA, FDA QSR (21 CFR Part 820/211), ISO 13485/9001, MolDx, etc
Understanding of regulatory frameworks relevant to the industry
Experience with audits, compliance systems, and regulatory submissions
Bachelor's degree (required) in life sciences, biology, chemistry, engineering, pharmacy, or related field
Preferred
Professional certification is a plus (e.g., Regulatory Affairs Certification – RAC, ASQ Certified Quality Auditor – CQA)
A Valid and active CLS (Generalist) or CGMBS license
Company
Pangea Laboratory
Pangea Laboratory provides bladder care, precision biome, and corporate test services.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Yap Ching Chew
Chief Operating Officer
Recent News
2026-01-22
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