Abbott Medical Events Specialist II in Alameda, California
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Responsible for timely review; documentation and filing of Medical Device Reports, including international vigilance reports for ADC products. Interact with 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. Work with Complaint Investigation Group to gather the appropriate information from a returned device investigation for submission of an MDR/Vigilance follow up report. Perform verification of MDRs/Viglance reports, including data complied for metrics, risk evaluations and various other MEG related activities. Support development of Medical Event Reporting guidance for new products. Provide consultation or support to new product teams regarding Reportability. Assure compliance to the ADC Medical Event and Quality System procedures.
Review medical complaints and potentially reportable events for the purpose of researching and gathering additional information needed to determine MDR and/or Vigilance reportability.
Document filing decision rationale in the Complaint Handling System.
Filing of all medical events and reportable malfunctions within the required timeframe.
Create compliant and practical solutions to cross-functional teams in order to promote accurate documentation of the complaint case, including MEG processes from a broader scale perspective.
Responsible for maintaining the Malfunction Reportability Assessment Matrix (MRAM), including updates to the Reportable Confirmed Malfunction List (RCML).
Demonstrates subject matter expertise; guidance, and training to other members of the Medical Events Group as well as to other functional departments.
Drive improvements to standard operating procedures, training and other tools used by for the Medical Events Group as required.
Perform other related duties and assignments as required.
B.A./B.S. degree is required, with preference being in a Technical/Scientific discipline. A RN, BSN, or Medically trained professional with knowledge of FDA/International guidelines for drug/medical device safety reporting requirements preferred. Requires a minimum of four (4) years experience working in a quality related role, or equivalent time in clinical laboratory, medical clinic, or nursing experience. Knowledge of FDA/International guidelines for drug/device safety reporting requirements preferred.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org