Analyst, Product Surveillance
3 weeks ago
Job Title: Analyst, Product Surveillance
Job Location: Plymouth, MN, U.S.A. 55442
Job Type: Contract (possible extension or convert to hire)
Pay: Starts at $22.00 an hour
Shift Structure: ONSITE, 8:00 AM - 4:30 PM, Monday to Friday, 40 hours per week
The Role of the Analyst, Product Surveillance:
* 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.
About the Analyst, Product Surveillance: The ideal candidate will have the following skills and experience:
* 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.
Come join the SMS team It takes more than top-notch facilities, modern equipment, and innovative technologies to become our customer’s most trusted supplier. It takes people who are committed to our customer’s success and who are willing to go the extra mile to get the job done right.
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