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Quality, Regulatory & Safety Director — Medical Devices

Job in Lexington, Middlesex County, Massachusetts, 02173, USA
Listing for: Cytonome/ST
Full Time position
Listed on 2026-08-20
Job specializations:
  • Quality Assurance - QA/QC
  • Healthcare
    Data Scientist
Salary/Wage Range or Industry Benchmark: 180000 - 240000 USD Yearly USD 180000.00 240000.00 YEAR
Job Description & How to Apply Below

Cytonome is seeking an experienced Head of Quality & Regulatory to lead the quality, regulatory and safety functions from its Lexington, MA office. The role requires building and guiding systems to meet ISO 9001, ISO 13485, FDA QSR and GMP requirements while aligning with product development and lifecycle management.

The candidate will manage the QARA team, oversee audits and regulatory filings, and ensure global compliance.

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