Medical Device Compliance Manager

5 days ago


Limerick, Limerick, Ireland Cook Medical Full time
Regulatory Expertise

The Regulatory Scientist 2 is responsible for ensuring that Cook medical devices comply with global medical device regulations for specific jurisdictions. Key areas of expertise include:

  • Understanding of regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820.
  • Development of global regulatory strategies for Cook medical devices.
Key Skills and Qualifications

To be successful in this role, you will require:

  • Third level qualification in Science, Engineering, or Clinical field such as Pharmacy or Nursing.
  • 2 years' experience in a regulated industry in a similar role.
  • Knowledge of regulations pertaining to Post-market Surveillance and Clinical Evaluation.


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