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Job Field: Legal Jobs
Location: Irvine, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Regulatory Affairs Specialist<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" />Every day, Kelly Scientific Resources (KSR) connects clinical research professionals with opportunities to advance their careers. We currently have an exciting contract opportunity for a Regulatory Affairs Specialist working with our client based in Irvine, CA.Purpose:This position is primarily responsible for the timely evaluation, completion and filing of adverse events under the MDR and MDV regulations. Responsible to maintain the quality process associated with MDR and MDV handling, procedures and controls to ensure that all MDR and MDV incidents are processed in accordance with established company procedures and worldwide regulations and standards.Job Responsibilities (other duties may be assigned):Ability to apply extensive knowledge of FDA and international regulatory requirements in order to independently make FDA reporting decision for both domestic and international complaints.Prepare and submit all MedWatch Reports (Initial and Supplemental) to the FDA within the required timeframes.Obtain and review reports, as appropriate, for OUS regulatory agencies and bodies, including European Union (Vigilance), Canada, Australia and Japan.Assist the Legal Department in collecting information for all complaints regarding litigation.Assess patient medical records for relevancy of the complaint and determine the seriousness of the reported event, as necessary.Ensure medical review and reportability review are completed in a timely manner for complaints that may be reportable to the government.Review complaint data and obtain additional information from affiliates, domestic accounts or field representatives, as required.Review product evaluation results to assess whether the data is accurate, thorough and appropriate as it relates to the complaint.Ensure that management is made aware of all unique and /or unusual events as they relate to reportable product complaints.Compose concise, complete, and informative customized complaint investigation response letters when requested by the complainant.Provide routine letters to customers for reports where use error is suspected.Assess completeness of entire complaint record (including MDR data) to ensure compliance with all relevant regulations and internal policies and procedures in order to close reportable complaints.Recognize complaint trends and potential product problems and report to management as appropriate.Provide support (and training) to global locations involved in complaint handling for reportable events to ensure compliance with applicable regulations and procedures.Develop customized complaint reports as needed.Gathers MDR data and assists in generating departmental metrics.Works effectively in a team environment to meet specified departmental metrics and objectives.Ensure timely closure of reportable complaint files in order to meet performance objectives for processing time.Interacts with regulatory bodies, international affiliates, customers and all levels of internal partners.Remain abreast of new or revised regulations and/or guidelines.Requirements:Bachelors Degree, R.N. or L.V.N. Degree with 1-4 years of Regulatory Affairs or Quality Assurance experience.Experience in a medical device manufacturing environment or other regulated environment required.Strong understanding and working knowledge of applicable domestic and international regulations (Quality System Regulation (specific to product complaint records), 21 CFR Part 820; Medical Device Reporting , 2CFR Part 803; Guidelines on Medical Devices Vigilance System, Medical Devices a

KEY REQUIREMENTS:

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