Remote QMS & Regulatory Affairs Leader

CEFALY Technology; Darien (CT); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health insurance

Dental and Vision

Disability insurance

Group Life Insurance

IRA with company match

Paid PTO

Paid holidays

Job summary

CEFALY Technology seeks an experienced Director to lead Quality Systems and Regulatory Affairs, driving QMS/eQMS optimization and audit readiness. You will partner with Operations, Supply Chain, and Product Development to ensure regulatory compliance across global activities.

The role requires 8–12+ years in medical devices, demonstrated leadership in audits, and hands‑on regulatory submissions. A remote or hybrid East Coast setup enables scalable growth and mentorship of teams.

Qualifications

• 8–12+ years QA/RA experience in medical devices.
• Experience leading audits and regulatory inspections.
• Implementing or improving electronic QMS platforms (Greenlight Guru preferred).
• Remediating quality system deficiencies and documentation gaps.
• Experience with FDA submissions and EU MDR activities.
• Strong leadership and mentorship capabilities.

Responsibilities

• Lead QMS/eQMS ownership, optimize roadmap, and governance.
• Oversee audits, evidence collection, and remediation strategies.
• Lead FDA and international regulatory submissions and agency interactions.
• Mentor junior QA/RA personnel and partner with cross‑functional teams.
• Drive continuous improvement in quality systems and inspection readiness.
• Maintain regulatory records and submission archives.

Skills

Quality leadership

Regulatory affairs leadership

QMS administration

eQMS administration

Audit & inspections

Cross-functional leadership

Documentation control

Change management

Regulatory strategy

Project management

Education

Bachelor's degree in Engineering/Life Sciences/Regulatory Affairs

Advanced degree preferred

Tools

Greenlight Guru

Job description

CEFALY Technology seeks an experienced Director to lead Quality Systems and Regulatory Affairs, driving QMS/eQMS optimization and audit readiness. You will partner with Operations, Supply Chain, and Product Development to ensure regulatory compliance across global activities.

The role requires 8–12+ years in medical devices, demonstrated leadership in audits, and hands‑on regulatory submissions. A remote or hybrid East Coast setup enables scalable growth and mentorship of teams.