Director, Quality Systems & Regulatory Affairs; Remote - East Coast

Director, Quality Systems & Regulatory Affairs

Department: Quality & Regulatory Affairs
Reports To: SVP, Operations
Location: Remote or Hybrid - East Coast ONLY
FLSA Status: Exempt, Full‑Time

CEFALY Technology is seeking an experienced Quality Systems & Regulatory Affairs leader to strengthen and scale the organization’s quality and regulatory infrastructure. This individual will serve as the functional lead for Quality Systems and Regulatory Affairs and will be responsible for improving organizational compliance, strengthening audit readiness, and reducing quality system risk through robust process ownership and execution.

A critical priority for this role will be optimizing and expanding the company’s electronic Quality Management System (eQMS), conducting comprehensive assessments of quality documentation and system effectiveness, and driving sustainable process improvements across the organization. This position will provide experienced leadership during notified body audits and regulatory inspections and will help build long‑term organizational capability through mentorship and process maturity.

The role serves as a strategic and hands‑on partner across Operations, Supply Chain, Customer Service, Product Development, and leadership teams to ensure compliance excellence and scalable growth.

• 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.
• Support registrations, renewals, amendments, and post‑market regulatory activities.
• Interpret changing regulatory requirements and proactively communicate implications.
• Maintain regulatory records and submission archives.

• Mentor and help develop junior QA/RA personnel.
• Provide quality and regulatory leadership across Operations,…