Sr. RAQA Compliance Analyst

Location: Allendale, NJ Salary: $32/hr Description: Our client is currently seeking a Sr. RAQA Compliance Analyst for a 12 month + contract.Description/Comment: Minimum 1 to 3 years experience in a medical device industry analyzing product complaints for reportability to the FDA/ European Competent Authorities. Managing US regulatory actions and coordinating with FDA and internal teammembers. Knowledge of regulatory requirements; 21 CFR, ISO 9001, euMDR, and Quality System Regulation. Ability to understand and explain detailed regulatory compliance programs or issues and comply with constantly changing regulatory requirements. Strong verbal, written and interpersonal skills. Must be able to work in a team environment. 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. Must be a positive, energetic team player, and an advocate for product excellence and quality. Candidate should be results oriented, multi-tasking, quick learner, respond to the urgent needs of the team and show a strong track record of meeting deadlines.Additional Job Details: 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 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 Corp and Spine policies and procedures.Contact: This job and many more are available through The Judge Group. Find us on the web at www.judge.com