Quality and Regulatory Affairs Analyst

UT Tyler; Arlington (TX); Hybrid; USD 106,000 - 108,000; Full time

Benefits offered by this job

Hybrid work environment

25% Travel

Position funded through 6/30/2027

Job summary

The University of Texas at Arlington seeks a qualified professional to provide hands-on quality systems and compliance support to TMAC clients, focusing on medical device and regulated industries.

Develops, implements, maintains, and improves quality management systems; conducts gap assessments and internal audits; and supports certification audits, regulatory inspections, remediation activities, and ongoing compliance.

Qualifications

• Bachelor’s degree and five years of experience in quality assurance, engineering, or related function in regulated industry.
• MDSAP training or experience preferred.
• ISO 13485 internal/auditor training preferred.
• CSA/CSV and 21 CFR Part 11 experience preferred.
• Client-facing consulting or project support experience desired.
• Experience with risk management, design controls, and verification/validation.

Responsibilities

• Develops, implements, maintains, and improves quality management systems per ISO 13485 and QMSR.
• Conducts gap assessments and internal audits; supports certification and regulatory inspections.
• Supports CAPA, document control, change control, training, and electronic quality systems.
• Provides technical and project support to senior TMAC staff on quality engagements.
• Collaborates with clients and cross-functional teams to improve compliance and performance.

Skills

ISO 13485

QMSR

CAPA

Document control

Risk management

Auditing

Quality engineering

Regulatory compliance

21 CFR Part 11

Project coordination

Education

Bachelor’s degree in Engineering, Life Sciences, Physical Sciences, Computer Science, Information Systems, Quality

Tools

Microsoft SharePoint

Job description

The annual salary for this position ranges from $106,100 to $107,500. The final offer will be commensurate with the candidate’s relevant experience and qualifications.

Purpose of Position

Provides hands‑on quality systems and compliance support to TMAC clients, primarily within the medical device and other regulated manufacturing industries. Develops, implements, maintains, and improves quality management systems; conducts gap assessments and internal audits; and supports certification audits, regulatory inspections, remediation activities, and ongoing compliance. Supports quality engineering, risk management, CAPA, document control, training, electronic quality systems, and related quality activities. Provides technical and project support to senior TMAC staff on quality and regulatory engagements and works independently on assigned deliverables. Collaborates with clients and TMAC cross‑functional teams to develop practical, sustainable solutions that improve compliance, audit readiness, and operational performance.

Essential Functions

Quality Management Systems:

• Develops, implements, maintains, and improves quality management systems for TMAC clients in accordance with applicable requirements, including ISO 13485 and FDA Quality Management System Regulation (QMSR). Develops and revises quality procedures, work instructions, forms, and records; supports document control, training, change control, CAPA, and other quality system processes; and assists clients with implementing practical and sustainable quality system solutions.

Audit and Compliance Support:

• Conducts quality system gap assessments and internal audits and supports TMAC clients in preparing for certification audits, regulatory inspections, and other external assessments.
• Reviews quality system documentation for compliance with applicable requirements, identifies gaps and areas for improvement, supports the development of corrective actions and remediation plans, and assists with tracking activities through completion.

Quality Engineering and Risk Management:

• Supports quality engineering and risk management activities for TMAC clients, including root cause analysis, corrective and preventive action (CAPA), nonconformance management, change control, risk assessments, Failure Modes and Effects Analysis (FMEA), design controls, and verification and validation.
• Reviews technical and quality documentation, identifies potential risks and compliance gaps, and supports the development and implementation of appropriate corrective actions and risk controls.

Electronic Quality Systems:

• Supports the implementation, administration, improvement, and validation of electronic quality management systems and other computerized systems used in regulated environments.
• Develops and reviews Computer Software Assurance (CSA) and Computer Software Validation (CSV) documentation; evaluates system changes for validation impact; and supports compliance with electronic records, electronic signatures, data integrity, and 21 CFR Part 11 requirements.

Client Project and Technical Support:

• Provides technical and project support to senior TMAC staff on quality and regulatory client engagements.
• Prepares project deliverables, conducts research, coordinates assigned activities, develops technical documentation and training materials, and supports regulatory compliance activities under the direction of senior technical staff.
• Communicates project status, findings, and action items to clients and project teams and assists with the timely completion of project objectives.

TMAC Cross‑Functional Support:

• Supports TMAC cross‑functional teams and organizational initiatives by providing quality, regulatory, and technical expertise as needed.
• Contributes to collaborative projects, client development activities, proposals, training programs, and other initiatives that support TMAC services and organizational objectives.

Other Duties:

• Performs other duties as assigned.

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Physical Sciences, Computer Science, Information Systems, Quality, or a related field, and five (5) years of progressively responsible experience in quality assurance, quality engineering, quality systems, or a related function within the medical device or other regulated industry; or an equivalent combination of education and experience.

Preferred Qualifications

• Medical Device Single Audit Program (MDSAP) training or experience.
• Experience with ISO 13485 internal auditor or lead auditor training.
• Experience supporting certification audits, regulatory inspections, or quality system remediation activities.
• Experience with Computer Software Assurance (CSA), Computer Software Validation (CSV), 21 CFR Part 11, electronic records, electronic signatures, and data integrity requirements.
• Experience in client‑facing consulting, technical training, or project support.
• Experience with risk management, design controls, and verification and validation activities.

Knowledge, Skills & Abilities

• Knowledge of medical device quality systems, ISO 13485, FDA Quality Management System Regulation (QMSR), and applicable quality and compliance requirements.
• Knowledge of CAPA, nonconformance management, change control, document control, training systems, risk management, and design controls.
• Ability to conduct internal audits and gap assessments, evaluate objective evidence, identify compliance gaps, document findings, and support corrective action and remediation activities.
• Knowledge of electronic quality management systems and data integrity principles.
• Skill in building, configuring, maintaining, and improving Microsoft SharePoint platforms to support document management, workflows, collaboration, and quality system processes (preferred).
• Strong analytical, problem-solving, technical writing, organizational, and project coordination skills.
• Ability to interpret quality and regulatory requirements and translate them into practical solutions.
• Ability to work independently on assigned activities while collaborating effectively with senior staff, clients, and cross‑functional teams.
• Strong written, verbal, presentation, and interpersonal communication skills.

Work Schedule

• Monday through Friday; 8:00am through 5:00pm
• Hybrid work environment (remote & office)
• 25% Travel
• Position funded through 6/30/2027

Working Conditions

• Driving is required and an essential part of the position.
• May work around standard office conditions.
• May work around chemicals.
• May work around electrical and/or mechanical hazards.
• Repetitive use of a keyboard at a workstation.
• Uses standard office equipment
• Prolonged sitting, standing, and walking required.

Benefits Information

Position is benefit eligible: Yes

We are proud to offer a comprehensive benefits package to our employees at the University.

It is the policy of The University of Texas at Arlington to conduct a pre employment background check on any applicant who is under final consideration for employment with the University.

This position may have access to critical infrastructure as defined by Section 113.001(2) of the Texas Business and Commerce Code. If so, to be hired for and continue to be employed in this position you must maintain the security or integrity of the infrastructure as set forth in Texas Executive Order GA 48. By assuming this position, and if you have access to critical infrastructure, you authorize the University to conduct routine background checks.

University Information

The University of Texas at Arlington (UTA) is located in the heart of the Dallas-Fort Worth-Arlington metroplex, a vibrant and diverse metropolitan area that is home to over 7 million people, one of the fastest-growing tech economies in the United States, and a wide array of arts, entertainment, and cultural activities. As a comprehensive teaching, research, and public service institution, UTA is dedicated to the advancement of knowledge through scholarship and creative work. With an enrollment of more than 42,000 students, UTA is the second largest in the University of Texas System. As a result of its combination of rigorous academics and innovative research, UTA is designated as a Carnegie R-1 “Very High Research Activity” institution and nationally recognized for its commitment to student success and service. It ranks No. 5 in Military Times’ “Best for Vets: Colleges” and is the top university in North Texas for its graduates’ salaries (The Wall Street Journal). UTA is designated as both a Hispanic‑Serving Institution and an Asian American and Native American Pacific Islander‑Serving Institution and is No. 6 for undergraduate ethnic diversity in the United States (U.S. News & World Report, 2023). With a global alumni network of approximately 280,000 – including leaders at many of the 24 Fortune 500 companies headquartered in North Texas – UTA contributes an estimated $29 billion annually to the Texas economy.

UTA is expanding its regional footprint by building a regional campus, called UTA West, in Parker County on the far west side of Fort Worth. It is scheduled to open in fall 2028. This initiative aligns with the university’s strategic growth and commitment to serving the broader community.

This is an exciting time to join UTA and contribute to its bold vision for the future.

EEO Statement

It is the policy of The University of Texas at Arlington (UTA or The University) to provide an educational and working environment that provides equal opportunity to all members of the University community. In accordance with federal and state law, the University prohibits unlawful discrimination, including harassment, on the basis of race, color, national origin, religion, age, sex, sexual orientation, pregnancy, disability, genetic information, and/or veteran status. The University also prohibits discrimination on the basis of gender identity, and gender expression. Retaliation against persons who oppose a discriminatory practice, file a charge of discrimination, or testify for, assist in, or participate in an investigative proceeding relating to discrimination is prohibited. Constitutionally‑protected expression will not be considered discrimination or harassment under this policy. It is the responsibility of all departments, employees, and students to ensure the University’s compliance with this policy.

ADA Accommodations

The University of Texas at Arlington is committed to providing reasonable accommodation to individuals with disabilities. If you require reasonable accommodation in completing this application, interviewing or otherwise participating in the employee selection process, please direct your inquiries to 817-272-5554 or email [e-mail].