Position Details

Type Contract

Experience mid

Exp. Years 1+ years

Education Bachelor's degree or equivalent education

Category QA & Testing

About this role

Contract QA Analyst II will analyze customer complaints for regulatory reportability in EP Complaint Management Center, investigate with data sources, and prepare MDRs and other regulatory reports in compliance with CFR.

Key Responsibilities

Review complaint communications and assess regulatory reportability
Investigate complaints collecting data from clinical staff, field reps, labs
Establish regulatory reportability decisions using event investigation models
Write Medical Device Reports (MDRs) and other regulatory reports
Communicate investigation results and corrective actions to physicians and end users

Technical Overview

Regulatory and quality-domain focus with CFR, MDR, Vigilance; regulatory decision modeling; cross-functional collaboration; hybrid work schedule.

Ideal Candidate

The ideal candidate is a contract QA analyst II with 1+ years of medical device complaint processing and CFR/MDR regulatory reporting, strong written and verbal communication, and the ability to coordinate with internal and field teams.

Must-Have Skills

Bachelor's degree or equivalent education1+ years of experience in medical device complaint processing & reportingExcellent written and verbal communication skills

Nice-to-Have Skills

Self-motivatedCritical thinkingTime managementBiology/Health Sciences/Engineering background

Required Skills

bachelor's degree or equivalent education1+ years of experience in medical device complaint processing & reportingexcellent written and verbal communication skillsregulatory reportingMDRCFRevent investigationvigilancecross-functional collaboration

Hard Skills

MDRsRegulatory reportingEvent investigationRegulatory complianceMedical device complaint processingRegulatory reports writingCoding eventsReviewing coding and investigationsCFRVigilance reportingMDR submissionsRegulatory decision modelsRegulatory updatesRegulatory guidelinesWritten communication

Soft Skills

communicationteamworktime managementcritical thinkingself-motivated

Industry & Role

Industry Healthcare & Medical

Job Function Analyze and report medical device complaints to regulatory authorities and ensure CFR/MDR compliance

Role Subtype QA Analyst II

Keywords for Your Resume

quality assurance analyst iimedical devicecomplaint processingregulatory reportingMDRVigilanceCFRregulatory reportsevent investigationclinical knowledgewritten communicationregulatory decisionscross-functional collaborationhybridmississaugatorontobiologyhealth sciencesregulatory guidelinesmedical device complaint processing

Deal Breakers

Bachelor's degree or equivalent education, 1+ years of experience in medical device complaint processing & reporting, Excellent written and verbal communication skills

Apply for this Position →

Get matched to jobs like this

Luna finds roles that fit your skills and career goals — no endless scrolling required.

Create a Free Profile

Quality Assurance Analyst II (Contract)

Get matched to jobs like this