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Director of Quality Systems & Regulatory Excellence

Job in Darien, Fairfield County, Connecticut, 06820, USA
Listing for: Cefaly US Inc
Full Time position
Listed on 2026-07-10
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 160000 - 180000 USD Yearly USD 160000.00 180000.00 YEAR
Job Description & How to Apply Below

CEFALY Technology seeks an experienced leader to strengthen and scale our quality systems and regulatory affairs. You will drive eQMS optimization, governance, and global compliance while coordinating audits and regulatory submissions.

The role requires 8–12+ years in medical devices QA/RA, strong leadership, and deep knowledge of ISO 13485, FDA QSR, and EU MDR. Join a fast‑growing team in Darien, CT with cross‑functional impact.

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