Abbott Medical Events Specialist I 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. Perform verification of MDRs/Vigilance reports; including support of data compiled for metrics, risk evaluations and various other MEG related activities. Assure compliance to the ADC Medical Event and Quality System procedures.
Review medical complaints and potentially reportable events for the purpose of determining MDR and/or Vigilance reportability. Document filing decision rationale in the Complaint Handling System. File 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. Aid in updates to standard operating procedures, training or other tools used by 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 two (2) years’ experience working in a quality related role, or equivalent time in critical laboratory, medical clinic, or nursing experience.
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