Senior Regulatory Strategist

4 days ago


Ennis, Clare, Ireland Cregg Group Full time
About the Role

We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at the Cregg Group. In this role, you will be responsible for developing and implementing regulatory strategies to support the timely and successful registration, approval, and maintenance of company and client products.

Your Key Responsibilities:
  • Develop and implement regulatory strategies to support the timely and successful registration, approval, and maintenance of company and client products.
  • Lead the research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products.
  • Provide regulatory direction to development project teams as a core team member.


You Will Be Responsible For:
  • Maintaining an excellent understanding of the global medical device regulations especially with respect to Biocompatibility for example ISO 10993, and by identifying and critically assessing emerging standards, theories and methodologies and applying gained expertise within the Biological safety processes.
  • Conduct comprehensive evaluations of biological risks associated with medical devices, ensuring compliance with ISO 10993 and regulatory requirements.


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