Director, Quality Systems – Regulatory Affairs

CEFALY Technology

Quality Systems & Regulatory Affairs leader at CEFALY Technology ensuring compliance and audit readiness across quality systems. Focus on QMS optimization and regulatory affairs for medical devices.

Posted 7/6/2026full-timeRemote • Connecticut • 🇺🇸 United StatesLead💰 $160,000 - $180,000 per yearWebsite

About the role

Key responsibilities & impact

Serve as system owner and business lead for the organization’s eQMS platform including optimization, implementation expansion, workflow design, governance, and user adoption
Assess current eQMS utilization and develop a roadmap for full implementation and process maturity
Own and administer day-to-day QMS and eQMS activities and processes
Lead continual improvement initiatives across quality system processes and documentation
Lead comprehensive audits of controlled documentation and quality records to identify inconsistencies, gaps, obsolete content, and systemic documentation deficiencies
Establish processes and controls ensuring consistency across SOPs, work instructions, forms, labels, templates, and quality records
Drive document control processes including creation, revision workflows, review cycles, training assignments, archival activities, and change management
Develop sustainable document governance practices to reduce repeat nonconformances and improve inspection readiness
Monitor quality metrics and identify opportunities for process improvements
Support and improve CAPA, nonconformance, complaint handling, change control, risk management, and supplier quality processes
Ensure QMS alignment with ISO 13485, FDA Quality System Regulation (21 CFR Part 820/QMSR), EU MDR, and applicable global requirements
Lead initiatives to improve quality system effectiveness, data integrity, and organizational compliance maturity
Maintain ongoing inspection and audit readiness
Act as primary Quality and Regulatory lead during notified body audits, FDA inspections, supplier audits, and external quality assessments
Lead audit preparation strategy, evidence collection, coordination activities, and response management
Drive audit finding remediation through root cause analysis and sustainable CAPA implementation
Support management review processes and quality reporting
Maintain a continuous state of organizational inspection readiness
Independently lead FDA and international regulatory submissions and agency interactions
Prepare, coordinate, and execute regulatory filings and lifecycle submissions
Conduct regulatory impact assessments related to product, process, manufacturing, supplier, labeling, and operational changes
Provide regulatory strategy recommendations and communicate business impact to leadership.
Mentor and help develop junior QA/RA personnel
Provide quality and regulatory leadership across Operations, Supply Chain, Customer Service, Product Development, and leadership teams

Requirements

What you’ll need

Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or related field required
Advanced degree preferred
8–12+ years of progressive Quality and Regulatory Affairs experience within medical devices
Demonstrated experience serving as lead quality or regulatory representative during notified body audits and regulatory inspections
Proven experience owning, implementing, or significantly improving an electronic QMS platform; Greenlight Guru experience strongly preferred
Demonstrated experience identifying and remediating systemic documentation and quality system deficiencies
Experience independently leading FDA submissions and EU MDR activities
Experience with CAPA, complaint handling, risk management, supplier quality, document control, and change management systems
Demonstrated success improving audit outcomes and quality system maturity
Prior people leadership or mentoring experience strongly preferred
Experience supporting Class II and/or Class III medical devices preferred

Benefits

Comp & perks

Health insurance (80% employer-paid)
Employer-paid Dental and Vision
Short-Term and Long-Term Disability
Group Life Insurance
IRA with company match (no vesting period)
Paid PTO
Paid company holidays

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality System Regulation (QSR)ISO 13485 ComplianceDocument Control ProcessesRegulatory SubmissionsCAPA ManagementChange ManagementAudit RemediationProcess ImprovementSystemic Documentation RemediationQuality Metrics Monitoring

Soft Skills

LeadershipMentoringCollaborationCommunicationProblem-Solving