MDR/Vigilance Specialist - 21860
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Contract opportunity through 1/31/2018
Title: MDR/Vigilance Specialist - 21860
**Must be able to be a direct W2 of Three Point Solutions, Inc. (H1B transfers available)**
Bachelor's degree required.
Degree in Science related discipline preferred.
Medical Device Reporting (MDR) experience required; clinical experience highly preferred.
Position responsible for reviewing medical summaries and assessing, updating and completing the complaint file with all relevant information which includes but is not limited to even description review, proper coding and the filing of supplemental MDRs. The candidate must possesses excellent analytical skills, attention to detail and excellent organizational skills. Medical device reporting experience is required and a clinical background is preferred.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Working within a product team with PMV Analysts at various levels:
• Receive medical summaries from MCS - Search by delivery date on MCS site
• Search complaint database (CTS) to identify patient in question
• Review medical summary to identify pertinent information which is required for the complaint.
• Upload medical summary to CTS file.
• Update all necessary fields within complaint record with relevant information from medical summary
• If necessary, create and file supplemental MDRs.
• Maintain the highest level of compliance to the Code of Federal Regulations, Medical Device Directive (European Union), Canadian Medical Device Regulations, Japan MHLW, China SFDA and Australian Regulations. Including the preparation and timely submission of all Medical Device Reports and Medical Device Vigilance reports with a focus on accuracy, precision and urgency.
• Closely monitor quality and timeliness of complaint files.
• Provide/ present data/ trends to other departments as necessary.
• Ensure obligations to internal/external customers are being performed in an accurate and timely fashion.
• Run weekly reports and enforce timely closure of investigations/ plant engineering investigations.
• Ad hoc reporting.