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