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Regulatory Affairs Specialist

Job description

Regulatory Affairs | 12-month contract | Galway.

Our client, one of Galway’s leading Medical Device companies is looking for a Regulatory Affairs specialist to join their team on a 12-month basis.

You will be responsible for the Regulatory Affairs support of the Galway site as well as submissions and compliance.

Responsibilities of the role include;

  • You would be reviewing and signing off on product and or manufacturing changes for compliance with regulations.
  • You would be initiating any regulatory submissions.
  • You would prepare and submit submission files such as 30-day notices as well as Real Time reviews.
  • Provide timely response to FDA questions.
  • You will review corporate SOPs.
  • You will participate in audits such as FDA, TGA, HPRA as well as other audits.
  • You would be working closely with middle and senior management on regulatory issues.

Requirements;

  • Third Level Degree (minimum level 8) in Science or Engineering.
  • 5 years’ experience in Regulatory Affairs.
  • Experience in Medical Device Industry is a must.
  • Experience in MDD, MDR, FDA, ISO, environment
  • Strong team member with the ability to identify and drive regulatory compliance improvements.
  • Excellent communication skills.

If you are interested in applying to this role please send an updated CV to Rebecca O'Connor at ROconnor@sigmar.ie or call 091 749265 for confidential discussion. 

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