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Post-Market Software Quality Lead — Infrastructure
Job in
Newton, Middlesex County, Massachusetts, 02165, USA
Listed on 2026-07-14
Listing for:
Jobtailor
Full Time
position Listed on 2026-07-14
Job specializations:
-
Business
Regulatory Compliance Specialist
Job Description & How to Apply Below
Jobtailor is seeking an experienced software quality professional to oversee post‑market surveillance and CAPA activities for medical device software. You will lead investigations, assess risk, and ensure regulatory alignment with FDA CFR, MDR, ISO 13485, and IEC 62304.
The role requires strong analytical abilities, exceptional communication, and the capacity to coordinate across multi‑disciplinary teams while ensuring audit‑readiness and formal documentation.
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