Job Detail

Location Galway
Salary Negotiable
Role Type Temporary
Contact Marchon Monroe

Regulatory Affairs Specialist

Regulatory Affairs Specialist

My client is a Galway based medical Device manufacture who are excited to offer a new position fort a Reg Affairs Specialist. As the Regulatory Affairs Specialist, you will support Product Development, Regulatory Complaint Management and Regulatory Approval on sustaining projects. This role would suit a candidate who has had Regulatory experience within the Medical Device industry and is looking to gain further experience to develop their career.

Job Details

  • Preparing technical documentation for submission to regulatory agencies.
  • Creation & maintenance of product design and technical documentation in compliance with the relevant regulations and standards.
  • Support the development and submission of high-quality regulatory files to the relevant ethical committees and regulatory agencies, ensuring successful approval.
  • Organise and maintain regulatory submissions with regulatory authorities.
  • Co-ordinate and conduct gap assessment activities in line with updated regulatory requirements and standards.
  • Keep up to date with changes in applicable regulatory requirements and standards.
  • Assist company preparation for inspection by a notified body and regulatory authorities.
  • Co-ordinate and progress Adverse Event reporting to regulatory authorities.
  • Ensuring adherence to all organisational and external regulatory requirements.

Required Qualifications

  • Minimum of Level 8 in a Scientific or other technical subject.
  • 2+ years of experience gained in similar Regulatory Affairs role.
  • Class III medical device experience would be highly advantageous.
  • knowledge of GMP, FDA QSR and ISO 13485 requirements is essential.

For further information on this Senior Supplier Quality role in Galway, please contact Marchon Monroe on 0860449473 /
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Regulatory Affairs Specialist

Marchon Monroe

Role Type Temporary
Contact Marchon Monroe
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