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Regulatory Affairs Specialist

1 week ago

Ennis, Clare, Ireland Cregg Group Full time
Job Summary

Cregg Group is seeking an experienced Senior Regulatory Affairs Specialist to join our team. This role will involve developing and implementing regulatory strategies to support the timely and successful registration, approval, and maintenance of company and client products.

The ideal candidate will have a strong understanding of global medical device regulations, particularly ISO 10993, and be able to effectively manage multiple projects and priorities. They will also have excellent attention to detail and be results-oriented.

Key Responsibilities:
  • Develop and implement regulatory strategies to support product registration, approval, and maintenance.
  • Provide regulatory direction to development project teams.
  • Coordinate multiple projects at one time and provide regular reports to regulatory management and others as required.
  • Maintain an excellent understanding of global medical device regulations.

Requirements:
  • Level 8 Degree or Masters in Science or Engineering or similar.
  • Minimum of 3 years experience in a similar role in the medical devices industry.
  • Regulatory experience in Medical Devices, Pharmaceuticals or similar regulated industry is required.
  • Understanding of applicable guidelines and regulations, for example experience with ISO 10993.