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Complaint Analyst - Medical Devices

Location : Upper Saddle River NJ US 07458
Job Type : Temp/Contract
Reference Code : 20251-BZ1
Compensation : open - 23-25/h
Start Date : 07/16/2020
Hours : Full Time
Required Years of Experience : 1
Travel : No
Relocation : No
Job Industry : Medical Devices

Job Description :

  • Contract position for a Complaint Analyst for medical device manufacturing, RAQA compliance.

  • Follow-up with Sales Reps and Hospitals to obtain applicable information pertaining to reported events.

  • Coordinate obtaining medical opinions in support of reporting and investigational purposes.

  • Work closely with R&D, Marketing, Advanced Reliability Engineers and Advanced Quality Engineers to assess patient risk and associated harms within the complaint investigation to accurately assess reportability decision.

  • Review PIs for reportability to the FDA and other competent authorities under Medical Device Reporting regulations.

  • Ensure timely completion of MDR rationales and initial, supplemental and final incident reports to FDA and other competent authorities within specified timeframes.

  • Coordinate with QA all documentation required to reach a decision regarding a field action as required by company policies and procedures.

  • Assess compliance concerns for non conformances, providing rationale.

  • Collect information for HHE's.

  • Provide Strategy on recalls.

  • Execute recalls, 806 reports, effectivity checks, periodic reports and coordination of recalls.

Required Qualifications :

  • Minimum 1 to 3 years experience in a medical device industry analyzing product complaints for reportability to the FDA/ European Competent Authorities.

  • Experience managing US regulatory actions and coordinating with FDA and internal team members.

  • Knowledge of regulatory requirements; 21 CFR, ISO 13485, euMDR, and Quality System Regulation.

  • Ability to understand and explain detailed regulatory compliance programs or issues and comply with constantly changing regulatory requirements.

  • Ability to work closely with engineers and other team members in understanding device functionality and surgical techniques in evaluating complaints for reportability purposes.

  • Excellent analytical, problem solving and troubleshooting skills.

Contact: Bill Zukowsky

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