Senior Medical Device Compliance Officer

6 days ago


Galway, Galway, Ireland beBeeRegulatoryAffairs Full time €80,000 - €100,000
Job Overview

We are seeking a Principal Regulatory Affairs Specialist to support our regulatory affairs department. This role will be responsible for facilitating the product development process, submissions, and ensuring regulatory compliance.

Main Responsibilities
  • Develop and maintain positive relationships with device reviewers through effective oral and written communications.
  • Support the implementation of departmental policies and procedures.
  • Provide Regulatory Affairs training to cross-functional groups.
  • Design and execute regulatory strategies for new and modified medical devices.
  • Act as a key member on manufacturing and development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.
Requirements
  • A bachelor's degree in a STEM field (regulatory affairs or relevant discipline).
  • A minimum of 7 years' experience in Regulatory Affairs or a related field within the medical device industry.
  • Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards.
Benefits

This position offers a challenging opportunity to develop your skills and expertise in Regulatory Affairs. If you have a strong background in regulatory compliance and excellent communication skills, we encourage you to apply.



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