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Analyst, Product Surveillance

In Minnesota / United States

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Analyst, Product Surveillance   

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JOB TITLE:
Analyst, Product Surveillance
JOB TYPE:

JOB SKILLS:
JOB LOCATION:
Minnetonka Minnesota / United States

JOB DESCRIPTION :
Analyst, Product Surveillance
Pay Rate: $30/HR


Skills: Related experience in post market surveillance in a Medical Device or Pharmaceutical Industry. At least one year of experience with MDR and OUS regulatory reporting experience required. Knowledge of the use, development, and regulatory environment of medical devices. Knowledge of 21 CFR Part 820, 198, Complaint Files, and 21 CFR Part 803, Medical Device Reporting.

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.

Position Details

Jun 14, 2021
S16204861293078889
Minnesota / United States
Minnetonka
A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Analyst, Product Surveillance    Apply

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Analyst, Product Surveillance
Pay Rate: $30/HR


Skills: Related experience in post market surveillance in a Medical Device or Pharmaceutical Industry. At least one year of experience with MDR and OUS regulatory reporting experience required. Knowledge of the use, development, and regulatory environment of medical devices. Knowledge of 21 CFR Part 820, 198, Complaint Files, and 21 CFR Part 803, Medical Device Reporting.

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.