Quality Assurance and Regulatory Specialist

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:

1. Develop implement and maintain quality management systems (QMS).
2. Conduct or coordinate internal audits supplier audits to ensure compliance with regulatory standards (e.g. CLIA CAP)
3. Oversee document control change control CAPA (Corrective and Preventive Actions) nonconformance management complaint handling and Medical Device Reporting (MDR)/Vigilance.
4. Coordinate proficiency testing programs and analyze results to identify areas for improvement.
5. Ensure all regulatory licenses are up to date.
6. Maintain quality documentation SOPs and testing procedures.
7. Prepare and present quality metrics and reports for management review.
8. Train and provide orientation to all new hire personnel; review all associated training documents; and monitor the competency process of testing personnel.
9. Be familiar with laboratory protocols and procedures for specimen processing operating equipment and instruments maintenance of designated laboratory environment and instruments and data analysis.
10. Review and approve product labeling packaging promotional materials and technical documentation for regulatory compliance.
11. Monitor changes in global regulations standards and guidelines; assess impact on company processes and recommend updates.
12. Collaborate with cross-functional teams (R&D manufacturing engineering clinical marketing) to ensure regulatory and quality requirements are integrated early in product development.
13. Lead or support management reviews training programs on regulatory/quality topics and continuous improvement initiatives.
14. Prepare submit and maintain regulatory documents filings and reports.
15. Coordinate with regulatory bodies for product approvals and certifications.
16. Monitor regulatory changes and update internal processes accordingly.
17. Follow Pangea Laboratory health and safety policies and procedures and are responsible for reporting violations and enforcing these policies and procedures.
18. 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

Bachelors degree (required) in life sciences biology chemistry engineering pharmacy or related field; advanced degree (Masters/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 a start-up type of environment not in by job description doesnt 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 $70000-$85000 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

Disclaimer: At Pangea we take the integrity of our hiring process seriously. Please be aware of fraudulent recruitment activities that may use our name to deceive job seekers. We will never ask for payment sensitive personal information or financial details during the recruitment process.

All legitimate communications will come from an official Pangea or TriNet Hiring email address. If you are contacted by anyone claiming to represent us using a free email service (e.g. Gmail Yahoo Hotmail) or asking for payment please treat this as fraudulent and report it immediately to