Medical Device Evaluation and Reporting

Greensboro, NC 27409

Post Date: 01/26/2018 Job ID: 7993 Industry: Pharma Pay Rate: $70.00 - $90.00

SUMMARY

Review complaints and conduct medical evaluation for the purpose of evaluation and regulatory reporting determination of product complaints. Position includes oversight of timely submission of initial and supplemental medical device reports (MDRs) to FDA as part of post market compliance activities within the complaint handling system.





RESPONSIBILITIES

  • Review and evaluate complaints for MDR reporting decisions in accordance with 21CFR 803 Medical Device Reporting and Canadian pharmacovigilance requirements in accordance with GUI-0102: Good Pharmacovigilance Practices (GVP) Guidelines



  • Conduct medical evaluations, gather information, communicate with medical professionals, end user, etc., for MDR determinations



  • Coordinate with complaint handling team to determine if the reported complaint was associated with a malfunction, serious injury or death and whether the complaint documentation is complete and accurate



  • Determine final reportability of complaints per MDR regulations in accordance with 21 CFR 803 when team is unable to come to a decision



  • Escalate any new, unknown risk or hazards for further evaluation and decisions



  • Review and evaluate complaints with new or additional information to determine if the complaint requires MDR reporting and file MDRs as required



  • Submit complaints requiring an MDR to the FDA within 5 or 30 days as required per 21 CFR 803



  • Submit complaints requiring a supplemental MDR to the FDA within 30 days of the new or added information that necessitates supplemental MDRs



  • Conduct Outside of the United States (OUS) reportability evaluations and notify the OUS Regulatory team of reportable events in a timeframe that respects the requirements of that event country



  • Work with multidisciplinary and cross-functional teams from various business units to ensure the timely completion and closure of reportable complaints.





QUALIFICATIONS

  • College Degree in Life Science BS, RN, LPN, preferred, Biomedical Science, or similar relevant clinical discipline, specifically or equivalent combination of education and experience



  • 3-5 years of regulatory or Nursing, Clinical or Biomedical staff or hospital facility administration



  • Medical Device or other FDA regulated industry; post market surveillance and handling of complaints for medical devices (Complaint Evaluation / Medical Device Reporting / Safety / Compliance) a plus



  • Ability to understand the potential implications of medical device malfunctions or failures and how these might impact patients or users



  • Ability to assess limited and conflicting information and make accurate decisions based on available data. Healthcare experience a plus



  • Experience with TrackWise or similar complaint handling database a plus



  • Workload planning and organizing to ensure efficient use of limited time and resources



  • Prioritizing own work to effectively achieve objectives and standards



  • Experience in good documentation practice and recordkeeping





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