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Product Surveillance Analyst
1 month ago
Location: Temecula CA 92591
Duration: 2 years
Onsite Position
Shift: 8:00 AM to 5:00 PM
Chat Note:
- 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
Job Description:
- Exempt/Non Exempt: Non ExemptYears
- Experience: 0 - 2 yearsSkills: Related experience in post market surveillance in a Medical Device or Pharmaceutical Industry preferred.
- 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.
