Responsible for timely review, documentation and filing of Medical Device Reports, including international vigilance reports for the division's products. Accountable for meeting the compliance requirements for Medical Device Reporting regulations including (803). This includes but is not limited to: the efficient and timely review, documentation and filing of potentially reportable events.
Review medical complaints and potentially reportable events for the purpose of researching and gathering additional information needed to determine MDR and/or Vigilance reportability.
Interact with cross functional teams (e.g. Customer Service, Complaint Evaluations Group and Complaint Investigations Group) to gather appropriate information to determine whether a complaint requires an MDR and/or Vigilance report and/or submit a MDR/Vigilance follow up report.
Document filing decision rationale in the Complaint Handling System.
Filing of all medical events and reportable malfunctions within the required timeframe.
Provide feedback and recommends solutions within the Quality team to promote accurate documentation of the complaint case.
Assist in maintaining the Malfunction Reportability Assessment Matrix (MRAM), including updates to the Reportable Confirmed Malfunction List (RCML).
Perform verification of MDRs/Vigilance reports, including support of data compiled for metrics, risk evaluations and various other activities.
Assure compliance to the division's Medical Event and Quality System procedures.
Interface with management and other functional areas to ensure that Potential Reportable Events (PREs) are obtained in a timely and consistent basis.
The documentation of the work of the Medical Event Analyst is scrutinized by the Regulatory Agencies on a regular basis and compliance is measured by the accuracy and completeness of these documents. Failure to properly evaluate or report complaints could result in observations from regulatory agencies.
Associate Degree or an equivalent combination of education and work experience. Minimum 2 years working in a quality related role, or equivalent time in clinical laboratory, medical clinic, or nursing experience.
ADC Diabetes Care
Alameda, California, United States of America
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)