Job Summary:
Quality Assurance & Regulatory Specialist ensures that products, processes, and documentation meet required quality standards and comply with all relevant regulatory frameworks. This role combines regulatory strategy/submissions with quality system implementation, audits, and continuous improvement to support product approval, and patient safety.
This position is full-time Monday-Friday 9AM to 5:30PM.
Essential Duties and 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.
Education and Experience:
- 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.
Education
Bachelor's degree (required) in life sciences, biology, chemistry, engineering, pharmacy, or related field; advanced degree (Master's/PhD) preferred.
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
About us:
Pangea Laboratory is a California-based diagnostics company founded in 2014. We focus on the precise, early detection of emerging diseases. Our mission is to have a positive impact on human life, by providing biomedical communities with reliable and high-quality testing services, delivering the data they need to diagnose and treat diseases in an effective and timely manner. Named a Top Workplace by the OC Register, Pangea Laboratory continues to be a place where employees feel engaged, connected, and energized about their work. If you are passionate about helping people in advancing science and working with awesome teams in a fast-growing company, we want to speak with you!
How We Work:
Our Values:
- Focus – Relentless Prioritization. When we decide the business priorities and initiatives to support those priorities, we execute with disciplined focus.
- Agility – Flexible and Proactive. In a start-up type of environment, “not in by job description” doesn’t ever come to mind. Although we are focused, we realize adaptability to unplanned environmental changes is required.
- Reliability – We are accountable to what we say we will do. We are reliable to our customers and to our teammates.
Decision Drivers:
What we always consider when making decisions
- Culture – How will it impact teammates and our work environment. Team first.
- Customer – How will it impact Physicians, Patients, Payors, and Partners
- Compliance – How will it impact quality, regulatory, and legal requirements
CORE Operating Behaviors
- Creative, resourceful problem solving. We embrace problems and look forward to creative problem solving.
- Clear, transparent, and effective communication. Willing to discuss, debate, and then execute on decision with no looking back.
- Leadership through influence and trust, not hierarchy.
Compensation:
The estimated base compensation range for this position is $70,000-$85,000 annually at the time of posting. Actual compensation details will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors.
Equal Employment Opportunity Employer:
Pangea Laboratory welcomes candidates of all backgrounds. These include sex, age, color, race, religion, marital status, national origin, ancestry, sexual orientation, gender, gender identity, gender expression, physical & mental disability, medical condition, genetic information, military and veteran status, or any other protected status as defined by federal, state, or local law.
Location:
Onsite – Pangea HQ – 14762 Bentley Cir. Tustin, CA 92780