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

Position Summary

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.

Essential Responsibilities

Quality Management System (QMS) & eQMS Leadership

• 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 rec