Director of Quality Systems & Regulatory Affairs (Remote – East Coast)

About the role

CEFALY Technology seeks an experienced leader to own and evolve its Quality Management System (QMS) and Regulatory Affairs function. This senior position will guide eQMS optimization, audit readiness, and regulatory submissions while partnering across operations, supply chain, and product development.

Key responsibilities

• Serve as system owner for the electronic QMS platform, driving optimization, workflow design, governance and user adoption.
• Lead comprehensive audits of documentation, identify gaps, and implement sustainable remediation and CAPA.
• Act as primary Quality and Regulatory lead during notified‑body audits, FDA inspections and supplier assessments.
• Independently prepare and submit FDA and international regulatory filings, and manage post‑market activities.
• Mentor junior QA/RA staff and provide cross‑functional quality leadership.

Required profile

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs or related field; advanced degree preferred.
• 8–12+ years progressive experience in medical‑device quality and regulatory affairs, including audit leadership.
• Proven track record of implementing or improving an electronic QMS, preferably Greenlight Guru.
• Prior people‑leadership or mentoring experience.

Required skills

• Electronic QMS administration (Greenlight Guru experience strongly preferred).
• Deep knowledge of ISO 13485, FDA QSR (21 CFR Part 820) and EU MDR.
• CAPA, risk management, document control and change management processes.
• Technical writing and documentation management.

What we offer

• 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 and company holidays