Regulatory Affairs Specialist
2 weeks ago
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:
- Implement PMS activities as defined in relevant Quality System procedures and Work Instructions.
- Support and lead improvements in Regulatory Post Market Systems.
- Participate in the implementation of Field Safety Corrective Action plans and related activities.
- Manage RA activities for Design Changes and Supplier-related changes, including reporting, assessment, and regulatory submissions.
Education & Training
- Bachelor's degree (Level 8 NFQ) or relevant Diploma in Engineering/Science or related discipline.
- At least 3 years' relevant experience in the medical device or pharmaceutical industry.
- 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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