Quality Systems & Regulatory Compliance Manager (ISO 13485 exp. Req. / Waterbury
Listed on 2026-07-31
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Quality Systems & Regulatory Compliance Manager
Location: near Waterbury, CT
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
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).