Analyst, Product Surveillance
ATR International

Job Info

<b>Job Description:</b><br><br> We are seeking an Analyst, Product Surveillance for a very important client <br><br>May perform multiple functions within the postmarket surveillance department Major responsibilities would include determining classification, review, and disposition of adverse events and medically related complaints for on-market products, including decisions on seriousness, reportability, and potential causality Complete FDA MDR and other outside competent authority regulatory reports.<br><br><b>Requirement:</b><br><br>The ideal candidate will possess the following qualifications: <br><br>* Med device - regulated by FDA, taking product complaints from Account Managers, sales managers, from cath lab, physicians, taking phone calls, data entry, analyzing complaints for reportability to competent authorities, reviewing reports, etc.<br><br>* 4-year BA Degree highly preferred - new graduates okay; Degree - open to type: biology, biotech, engineering good fits (Life sciences) Masters okay as long as they are interested in position long term as this is a 2 year contract.<br><br>* 2-year degree with 2+ years complaint handling experience okay<br><br>* PhD/MBA candidates considered overqualified<br><br>* Critical thinking skills required<br><br>* Previous compliant experience preferred<br><br>* Need to have good documentation skills<br><br>* Previous med device experience nice to have<br><br>* Previous quality experience nice to have<br><br>* Entering data into online management system; Salesforce platform will be used - custom to group<br><br>* Reference documents and apply to daily work<br><br>* Organized, self-motivated, team player<br><br>* Good written and verbal communication<br><br>* MS Office experience preferred<br><br>* Worker will be assigned to team that work in same product group - will work with trainer daily until they are certified, 4-6 months of training<br>#PandoPandoLogic. Keywords: Casino Surveillance Officer, Location: Temecula, CA - 92593