Director, Global Quality & Regulatory Affairs

Fulgent Genetics; California, El Monte (MO, CA); On-site; USD 150,000 - 165,000; Full time

Job summary

An established industry player is seeking a Director of Global Quality and Regulatory Affairs to lead and oversee quality functions in a fast-paced environment. This role is pivotal in ensuring compliance with global regulatory frameworks and maintaining the highest quality standards for diagnostic testing. The successful candidate will drive the organization towards full IVDR compliance while leading a team of quality professionals. This is an exciting opportunity to make a significant impact in the biotech field and contribute to transforming patient care through innovative genomic testing solutions.

Qualifications

• 9+ years of experience in quality assurance or regulatory affairs.
• Strong knowledge of ISO standards and FDA regulations.
• Experience in senior leadership roles.

Responsibilities

• Lead global regulatory strategies for clinical laboratory tests.
• Ensure compliance with international regulations and standards.
• Oversee quality management systems across lab sites.

Skills

Regulatory Affairs

Quality Management Systems

Leadership

Strategic Problem-Solving

Compliance Knowledge

Communication Skills

Cross-Regional Team Management

Education

Bachelor's Degree

Master's Degree

Doctoral Degree

Tools

Microsoft Office Suite

Job description

Job Details

Senior Fulgent 4399 El Monte - El Monte, CA IDX Coppell TX Site - Coppell, TX Full Time 4 Year Degree Level Job Location Secondary Job Location(s) Position Type Education Level

$150000.00 - $165000.00 Salary/year Biotech Salary Range Job Category

Description

About Us

Founded in 2011, Fulgent has evolved into a premier, full-service genomic testing company built around a foundational technology platform.

Through our diverse testing menu, Fulgent is focused on transforming patient care in oncology, anatomic pathology, infectious and rare diseases, and reproductive health. We believe that by providing a wide range of effective, flexible testing options in conjunction with best-in-class service and support, we can redefine the way medicine is managed for patients and clinicians alike.

Since integrating with our therapeutic development business, Fulgent is also developing drug candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform. By merging our fields of expertise, we aim to become a fully integrated precision medicine company.

Summary of Position

Job Location: El Monte (Los Angeles), CA OR Coppell (Dallas), TX

The Director of Global Quality and Regulatory Affairs plays a critical role to lead and oversee all quality and regulatory functions supporting our clinical laboratory operations, including compliance with IVDR and other global regulatory frameworks. This leader will play a critical role in ensuring that our diagnostic testing, products, and processes meet all regulatory requirements, uphold the highest quality standards, and align with our global business strategy.

The Director must be familiar and experienced in CAP, CLIA, New York / California / Georgia / Texas / Massachusetts State, Federal regulations and certification standards, IVDR regulations, as well as be responsible for ensuring full compliance to all relevant laws and regulations.

Key Job Elements

Regulatory Affairs (Global)

• Lead global regulatory strategies and submissions for clinical laboratory-developed tests (LDTs), in vitro diagnostics (IVDs), and companion diagnostics.


• Ensure ongoing compliance with applicable international regulations, including:
  
  
  
  • EU IVDR
  
  
  • FDA (21 CFR Part 820, 812, 11)
  
  
  • CLIA, CAP, ISO 15189, ISO 13485
  
  
  • Other applicable regional regulations (e.g., MolDx, CLEP submissions)
  
  
  
  


• Oversee preparation and submission of technical files and CE marking under IVDR.


• Develop and maintain regulatory intelligence to anticipate changes in the regulatory landscape.


• Lead the organization's transition to full IVDR compliance, including gap assessments, documentation remediation, and notified body engagement.


• Manage planning and execution of performance evaluation plans, post-market surveillance, and vigilance reporting aligned with IVDR requirements.

Quality Management Systems

• Lead the development, implementation, and continuous improvement of global QMS across all lab sites.


• Ensure QMS compliance with ISO 13485, 15189, and applicable GxPs.


• Oversee internal/external audits, inspections, and corrective/preventive action (CAPA) programs.


• Champion a global culture of quality, accountability, and compliance.

Leadership & Strategic Influence

• Lead and develop a global team of quality and regulatory professionals for all lines of business.


• Serve as the key point of contact for regulatory agencies and notified bodies.


• Collaborate cross-functionally with R&D, Clinical Affairs, Operations, Legal, and Commercial teams to support product lifecycle, regulatory strategy, and lab readiness.


• Act as a thought leader and executive sponsor for regulatory strategy.

Risk Management

• Implement a risk management framework across all processes.


• Reevaluate risk profile when changes are made to the tests or device by updating the FMEA.

Qualifications

Knowledge/Experience

• A bachelor's degree with 9+ years of experience, or a master's degree with 7+ years of experience, or a Doctoral degree with 4+ years of experience, preferably in areas of medical devices, laboratory-developed tests, or quality assurance.


• At least 5+ years in a senior leadership management role.


• Strong knowledge of Quality, Regulatory compliance, and operations systems and processes, including GMP and QSR requirements for medical devices. (EU IVDR, ISO15189, ISO13485, FDA's QSRs, CAP, CLIA) is required.


• Proficiency in the Microsoft Office suite of products is required.


• Knowledge of domestic and international quality systems and other standards such as FDA QSR, ISO15189, ISO 13485, ISO 14971 and other applicable standards and regulations.

Skills

• Prior experience and a strong understanding of quality and regulatory documentation, processes, and procedures.


• Management-level healthcare experience or laboratory regulatory compliance experience, essentially including FDA, IVDR, CAP/CLIA, New York CLEP laws and regulations.


• In-depth understanding of compliance, operational, financial, quality assurance, and HR procedures and regulations.


• Certification in Regulatory Affairs Certification (RAC), LEAN Six Sigma, or Quality certification by the American Society for Quality.


• Proven track record of successful regulatory submissions (eg. IVDR, MolDx, CLEP) and inspections.


• Strong leadership, communication, and strategic problem-solving skills.


• Experience managing cross-regional teams and global operations.

Reports To

• Vice President, Operations & Compliance

Environment

Fulgent Therapeutics LLC is an Equal Employment Opportunity Employer.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. The term "qualified individual with a disability" means an individual with a disability who, with or without reasonable accommodation, can perform the essential functions of the position.

Safety and Work Environment:

• General office environment. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.


• Maintains a clean, neat, and orderly work area.


• Adheres to Department Specific Safety Guidelines.

Physical Demands:

• Standing, sitting, walking, bending, reaching, manual manipulation, and lifting up to 10 pounds.


• Must pass a color vision test if responsibilities require color discrimination.

For California residents, please see the link below to access our CCPA Privacy Notice.

CCPA Privacy Notice for California Residents

https://tinyurl.com/FulgentCCPA

Please note that Fulgent (and its affiliated companies, including Inform Diagnostics and CSI Laboratories) does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Search firms or agencies without an applicable contract and/or express approval to recruit for the role in question - that choose to submit a resume or client information to our career page or to any employee of Fulgent - will not be eligible for payment of any fee(s), and any associated shared data will become the property of Fulgent.