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.
- 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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