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Regulatory Compliance Expert

1 week ago

Limerick, Limerick, Ireland Life Science Recruitment Full time
Key Skills and Qualifications

We are looking for a highly skilled Process Chemist with strong knowledge of medical device quality standards ISO13485/FDA practices and GMP, GLP or similar regulated industry standards. The successful candidate will have:
  • A Bachelor's degree, Masters or PhD is required, preferably in engineering/science or a related field.
  • A minimum of 3 years' relevant experience with CMC.
  • Familiarity with FDA, US Pharmacopeia and/or European Pharmacopeia and ICH CMC regulatory topics.
  • Proven analytical and problem-solving skills.


In addition to the above qualifications, you will also need to have strong interpersonal skills and the ability to communicate across functions.