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Regulatory Affairs Specialist 2

Requisition ID 2025-16220
Job Location(s)
Limerick Ireland
Job Locations
IE-Limerick
Languages Required
English
Travel
None
Company
Cook Ireland
Position Type
Temporary
Category
Regulatory Affairs
Education
Associate's Degree/Diploma, Bachelor's Degree, Certificate, Secondary/High School Diploma/GED

Overview

The Regulatory Affairs Specialist 2 helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates, distribution partners or regulatory authorities.

Reporting to: Team Lead, Regulatory Affairs or

Manager, Regulatory Affairs

Find out more about Cook Medical here

Responsibilities

  • Maintain an excellent understanding of global medical device regulations for specific jurisdictions as assigned such as regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required. Knowledge of relevant ISO, Eu, FDA medical device standards regulations is required.
  • Ensures a thorough understanding of the products and/or regions they are assigned.
  • Communicates country/region specific regulatory requirements

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Cook Medical is proud to be an equal opportunity employer and we know that diversity makes us stronger and better as a company. Every day we make life-saving products and do what is best for patients worldwide, and the people that join Cook make this possible. In keeping with our Cook Group values, we are committed to treating all employees equally regardless of gender, civil status, family status, sexual orientation, religious belief, age, disability, race or membership of the traveller community. It is our policy to ensure that as much accommodation as possible is carried out to facilitate the participation of all individuals to ensure equity in the recruitment process and in the workplace