Regulatory Affairs Specialist

5 days ago


Limerick, Limerick, Ireland Cook Medical Full time

Overview

Cook Medical is a leading manufacturer of medical devices, and we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will play a crucial role in ensuring that our products meet the highest standards of quality and safety.

Responsibilities
  • Assist in the running of Cook Medical's regulatory affairs programs in accordance with internal procedures and regulatory requirements.
  • Implement regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745, and FDA 21CFR Part 820 as required.
  • Maintain an excellent understanding of global medical device regulations and stay up-to-date on any changes or updates.
  • Develop global regulatory strategies for Cook Medical devices in collaboration with other regulatory affairs or clinical personnel.

The ideal candidate will have a third-level qualification in science, engineering, or a related field, and at least two years' experience in a regulated industry in a similar role. A good understanding of relevant ISO, EU, and FDA medical device standards and regulations is also essential.



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