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MDR/Vigilance Specialist

Company: US Tech Solutions
Location: Minneapolis
Posted on: May 19, 2019

Job Description:

Job Title: MDR/Vigilance Specialist Job Id:16028 Location:Mounds View MN USA 55112 Duration:24 Months Position Description: Participates in the company's medical device and/or drug surveillance platform; including the intake, evaluation, processing, and follow-up on product performance events, complaints, and adverse reports. The MDR/Vigilance Specialist analyzes events reported from multiple inputs on Cardiac Rhythm and Heart Failure Management (CRHF) and AFS (Atrial Fibrillation Solutions) products to determine complaint status and regulatory reportability. In addition, this position supports the ongoing monitoring of product performance. Works cross-functionally to ensure maintenance and review of events and complaints, reporting of Medical Device Reports (MDRs), ADE data, or adverse reaction data, as set forth by the FDA and other regulatory agencies. Requires follow-up internally and externally to assure complete and accurate event files, complaint detail, and product performance information. Supports and represents complaint handling in internal and external audits and inspections. Position Responsibilities: Electronically process events to determine complaint and reportability status. Complete applicable Medical Device Reports (MDR) and Vigilance Reports as required per internal policy & procedures and FDA and other regulatory body regulations. Ensure complaint investigations are adequate, accurate, detailed and timely. Perform tasks to obtain adequate information to ensure proper documentation and closure of each complaint. Collaborate with appropriate technical, Clinical, Field/Sales and/or returned product analysis employees to determine reporting eligibility. Complete electronic submission of MDRs to the FDA. Ensure accurate data entry, scanning, and retention of documents to complete event files. Support internal systems, methods, and procedures to maintain compliance. Develop and maintain product knowledge of CRHF and AFS products. Assist in inspection support for FDA and global regulatory agencies. This may include research and preparation of correspondence in response to global regulatory agencies requests for additional information. Develop and maintain a working knowledge of regulations and standards related to post-market quality & complaint handling. Complete projects as assigned and required specific to post-market quality and complaint handling. Basic Qualifications EDUCATION REQUIRED: Bachelor's Degree YEARS OF EXPERIENCE: At least one year of transferable experience in a health, clinical, technical, or scientific field with a Bachelors Degree Desired/Preferred Qualifications: Attention to detail Strong communication skills Can work independently in a team environment Takes initiative and proactively seeks quality solutions through continuous improvement Knowledge of AFS products and therapies Experience in a clinical or regulated environment Lean Sigma Experience (Green Belt/Black Belt) Experience with complaint handling, MDR/Vigilance reporting Knowledge of 21 CFR Part 820, Quality System Regulations Knowledge of 21 CFR Part 803, Medical Device Reporting Knowledge of 45 CFR Parts 160 and 164, The Privacy Rule, HIPAA Effective priority setting Solid knowledge of word processing, spreadsheet, database and presentation applications Contact Person: Manju If you are interested in this job then you can reach me at 2015249600 X 7944

Keywords: US Tech Solutions, Minneapolis , MDR/Vigilance Specialist, Other , Minneapolis, Minnesota

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