Regulatory Affairs Specialist

5 days ago


Dublin, Dublin City, Ireland beBeeRegulatory Full time €80,000 - €100,000
Regulatory Affairs Professional

The ideal candidate will have a strong background in regulatory affairs, specifically in medical devices.

Main Responsibilities:
  • Develop and implement regulatory strategies to ensure compliance with European and US regulations.
  • Support the creation and maintenance of product design and technical documentation in accordance with relevant regulations and standards.
  • Develop and submit high-quality clinical and regulatory files to ethical committees and regulatory agencies.
  • Organise and maintain regulatory submissions with regulatory authorities and clinical investigation sites.
  • Coordinate gap assessment activities and stay up-to-date with changes in applicable regulatory requirements.
Requirements:
  • Bachelor's degree in science, engineering or related field.
  • Proven track record in a similar role with at least 5 years' experience in medical device regulatory affairs.
  • Extensive knowledge of quality management systems, design controls and current International and European regulations.
  • In-depth knowledge of EU Medical Device Directive and MEDDEV guidance documents.


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