Medical Device Regulatory Expert

1 week ago


Shannon, Ireland Sigmar Recruitment Full time

About Sigmar Recruitment:

We are a recruitment agency working closely with leading employers to help you find your next role. We have an exciting opportunity for a Senior Regulatory Affairs Specialist to join our client, a company that advances the development of life-changing medical technologies.

Key responsibilities include:

  • Leading research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products.
  • Providing routine regulatory information and regulatory direction to development project teams as a core team member.
  • Reviewing proposed labeling/instructions for use for compliance with applicable local and international regulations.

Requirements:

  • Level 8 Honour's Degree Science or Engineering bachelor's degree/master's with a minimum of 3-5 years relevant experience with medical devices.
  • Regulatory experience in Medical Devices, Pharmaceuticals or similar regulated industry is required.
  • Understanding of applicable guidelines and regulations, including experience with ISO 10993, FDA regulatory requirements, European Medical Devices Regulation (EU MDR), and international regulatory agency requirements.


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