Director, Quality Assurance - Regulatory

Role: Director, Quality Assurance – Regulatory for enterprise-wide specimen collection kit programs, providing strategic and operational quality leadership. Responsibilities: oversee design, implementation, and maintenance of a compliant QMS aligned with FDA 21 CFR 820 and ISO 13485, ensuring quality throughout the kit lifecycle; serve as Management Representative; collaborate with Regulatory Affairs; manage vendor quality oversight, audits, CAPA, complaint handling, and risk management; monitor quality metrics and support continuous improvement; and lead quality risk mitigation. Requirements: Bachelor’s in biology, chemistry, engineering, or related field; 15+ years in diagnostics, medical devices, or diagnostic labs with 3+ years in compliance under 21 CFR 820 or ISO 13485; experience supporting FDA inspections and audits; strong knowledge of quality systems, risk management, and supplier oversight. Preferred: familiarity with laboratory developed tests, CAP/CLIA framework, and medical device regulations; excellent communication and influencing skills; strategic problem-solving. High-Value: medical device regulation (21 CFR 820, ISO 13485), risk management, supplier quality, QMS design, and audit support. WorkSetup: not specified; salary range $130K-$150K; eligible for annual bonus and benefits.