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Medical Device Complaints & Regulatory Specialist

Job in Elizabeth, Union County, New Jersey, 07215, USA
Listing for: Spectrum Vascular
Full Time position
Listed on 2026-08-11
Job specializations:
  • Healthcare
  • Quality Assurance - QA/QC
Salary/Wage Range or Industry Benchmark: 65000 - 90000 USD Yearly USD 65000.00 90000.00 YEAR
Job Description & How to Apply Below

Spectrum Vascular seeks a Complaint Specialist to receive, document, investigate, and resolve product complaints in compliance with FDA QMSR, ISO 13485, EU MDR, and global requirements. You will work cross-functionally with Quality, Regulatory, Engineering, and CMOs to ensure timely resolution and continuous product improvement.

The role emphasizes regulatory reporting, trend analysis, and PMS activities, with a focus on maintaining confidentiality of complaint files and records.

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