- Determining the classification, review, and disposition of adverse events and medically related complaints for on-market products.
- Making decisions on the seriousness, reportability, and potential causality of these events.
- Completing FDA MDR (Medical Device Reporting) and other outside competent authority regulatory reports.
- Will work in the lab, assisting with returned product root cause investigations and evaluation submissions.
- May also be tasked with assisting in the complaint handling process, including intake, processing, and reporting on product experiences.
- 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.
- Related experience in post-market surveillance in a Medical Device or Pharmaceutical Industry preferred.
- Degreed applicants without medical, scientific, or complaint handling experience may be considered if they possess the strengths suitable for this position.
- Candidates with excellent organizational skills, a history of understanding and complying with policies and procedures, medical device reporting, or customer service experience are a plus.
- Candidates with a technical background or a history of root cause analysis/failure analysis, electrical, miscellaneous lab, or engineering tasks are a plus.
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Analyst, Product Surveillance - Plymouth, United States - SMS Staffing Inc.
