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