Quality and Regulatory Affairs Analyst

About the role

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.

Responsibilities

• 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