Quality Systems & Regulatory Compliance Manager

Quality Systems & Regulatory Compliance Manager

• Location: near Waterbury, CT
• Salary: $90,000–$120,000 + Annual Bonus Potential + Benefits
• Benefits: Medical, Dental, Vision, 401(k) w/ match, Holidays, PTO
• Job Type: Full-Time | On-site
• Typical Hours: Monday–Friday, 40 hours/week

Start Date: ASAP

• Sponsorship is not available
• Relocation assistance available

Quality Systems & Regulatory Compliance Manager Description

Our client in precision manufacturing is looking for a Quality Systems & Regulatory Compliance Manager to join its team near Waterbury, CT. You will own regulatory compliance and audit coordination, while partnering with a Quality Engineer to resolve customer complaints, conduct root-cause analysis and drive corrective and preventative actions. This role requires experience owning ISO 13485 compliance in a precision-manufacturing environment and audit participation. You must also understand FDA requirements, CAPA, and customer quality processes. This is a great opportunity to learn from the current leader during a planned transition before taking full ownership of the function at a financially strong manufacturer, investing in new technology, employee development, and long-term growth.

Quality Systems & Regulatory Compliance Manager Responsibilities

• Own regulatory and quality-system compliance programs
• Maintain regulatory filings, certifications, and supporting records
• Monitor FDA, ISO 13485, QMSR, ITAR, and EAR requirements
• Coordinate customer complaints, root-cause analysis, and CAPAs
• Lead customer audits and verify timely closure of findings
• Manage internal audits, auditor training, and corrective actions
• Track complaint trends, audit findings, PPM, and customer quality metrics
• Escalate compliance risks and stop processes that violate requirements
• Support customer quality agreements and document-control processes
• Train teams on regulatory, audit, and documentation requirements

Quality Systems & Regulatory Compliance Manager Qualifications

• 7+ years of regulatory compliance or quality-system ownership experience required
• ISO 13485 and FDA QMSR/21 CFR Part 820 compliance experience required
• Customer complaints, CAPA, root-cause analysis, and audit experience required
• Working knowledge of ITAR/EAR and environmental compliance required
• Microsoft Office proficiency required