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Post Market Surveillance Specialist 1 (Contract)

Company

Cook Medical

Location

Limerick, Ireland

Type

Contract

Overview

The Post Market Specialist serves as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory authorities and assists in assessing complaints for Regulatory Reporting, this includes Adverse Event Reporting (MDR, Vigilance, , Post Market Surveillance Activities (PMS), field action and associated correspondence to applicable Regulatory bodies.

Reporting to: Team Lead, Post Market Surveillance

Responsibilities

  • Assess complaints from Cook global customer support and delivery centres for adequate information to determine if event meets Regulatory Reporting requirements.
  • Utilize appropriate complaint software systems for processing complaints to/from customer support and delivery centres and QE Investigation functions.
  • Generate appropriate regulatory reports based on assessment.
  • Liaise effectively with regulators on all issues with regard to regulatory repor...
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