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Analyst, Product Surveillance II

CorTech LLC

This is a Full-time position in Plano, TX posted July 11, 2021.

Analyst, Product Surveillance II
Shift: 8:30am-5:30pm

CorTech is looking to hire a Analyst, Product Surveillance II in Plano, TX.

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 post market 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.