Director, Quality Systems & Regulatory Affairs

Director, Quality Systems & Regulatory Affairs

Darien, Connecticut, United States

CEFALY Technology is the maker of CEFALY, an FDA‑cleared, over‑the‑counter wearable medical device that’s clinically proven to relieve migraine pain and reduce migraine frequency. Migraine affects more than 1 billion people worldwide and can be difficult to treat with medication. CEFALY provides drug‑free migraine relief without a prescription and with minimal side effects by using external trigeminal nerve stimulation (e‑TNS) to desensitize the trigeminal nerve.

The company is based in Belgium with U.S. offices in Darien, Connecticut and manufactures specialized electronics for medical applications.

CEFALY Technology is seeking an experienced Quality Systems & Regulatory Affairs leader to strengthen and scale the organization’s quality and regulatory infrastructure. The role will serve as functional lead for Quality Systems and Regulatory Affairs, improving compliance, audit readiness, and quality system risk through robust process ownership and execution. A critical priority is optimizing and expanding the electronic Quality Management System (eQMS), conducting comprehensive assessments of quality documentation and system effectiveness, and driving sustainable process improvements across the organization.

The position includes leadership during notified body audits and regulatory inspections, mentoring, and building long‑term capability.

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 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…