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Compliance Analyst

Company: The Judge Group, Inc.
Location: Leesburg
Posted on: September 30, 2019

Job Description:

Location: Leesburg, VA Salary: $20-$23 Hourly Description: Our client is currently seeking a Compliance Analyst 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 team members. - 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 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 policies and procedures.

Contact: This job and many more are available through The Judge Group. Find us on the web at - provided by Dice

Keywords: The Judge Group, Inc., Leesburg , Compliance Analyst, IT / Software / Systems , Leesburg, Virginia

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