Analyst, Product Surveillance
26531 Ynez Road Temecula, CA 92591 US
Job Description
Education: Four-year degree, preferably in the healthcare or science fields; or 2-year degree and relevant experience supporting complaint handling investigations, medical device reporting, or product analysis. Degreed applicants without medical, scientific, or complaint handling experience may be considered if they possess the strengths suitable for this position.
Duties: 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.
• 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.
• 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.
• 2-year degree with 2+ years complaint handling experience okay
• PhD/MBA candidates considered overqualified
• Critical thinking skills required
• Previous compliant experience preferred
• Need to have good documentation skills
• Previous med device experience nice to have
• Previous quality experience nice to have
• Entering data into online management system; Salesforce platform will be used – custom to group
• Reference documents and apply to daily work
• Organized, self-motivated, team player
• Good written and verbal communication
• MS Office experience preferred
• 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
• Interview Process: Initial video screen, 1 follow up interview with selected candidates from screening
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