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Medical Device Compliance Specialist

7 days ago

Ennis, Clare, Ireland Cregg Group Full time
Role Overview

The Cregg Group is currently seeking a highly skilled Senior Regulatory Affairs Specialist to join their team. As a key member of the regulatory team, 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.

Main Objectives:
  • To develop and implement regulatory strategies that support the timely and successful registration, approval, and maintenance of company and client products.
  • To maintain 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.


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 Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745 and international regulatory agency requirements.