Role: Regulatory Affairs Engineer
Location: Parkmore, Galway (Hybrid working)
Benefits: Top salary
Company:
My client is a growing Medical Device company that has recently moved into a high-tech new site in Parkmore. They have developed innovative technology to improve the performance of Vascular stents.
Role:
Reporting to the Senior Regulatory Affairs Manager, as a Regulatory Affairs Specialist, you will play a key role in the implementation of post-market activities. This is a fantastic opportunity to gain international experience while working as part of a supportive, collaborative team in the state-of-the-art facility in Galway.
Responsibilities:
1. Implement PMS activities as defined in relevant Quality System procedures and Work Instructions.
2. Support and lead improvements in Regulatory Post Market Systems.
3. Participate in the implementation of Field Safety Corrective Action plans and related activities.
4. Manage RA activities for Design Changes and Supplier-related changes, including reporting, assessment, and regulatory submissions.
Education & Training
1. Bachelor’s degree (Level 8 NFQ) or relevant Diploma in Engineering/Science or related discipline.
2. At least 3 years’ relevant experience in the medical device or pharmaceutical industry.
3. Experience in Regulatory Affairs/Quality Assurance is preferred.
To apply or for more info, call me at 087 0612325 or email Thomas.gallagher@lifescience.ie
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