Role: Regulatory Affairs Engineer
Location: Parkmore, Galway (Hybrid working)
Benefits: Top salary


Company:
My client are a growing Medical Device company who have recently moved into a high tech new site in Parkmore. They have developed an innovative new 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 a key role in the implementation of post-market activities within Veryan. This is a fantastic opportunity, which will allow you to gain international experience while working as part of a supportive, collaborative team in the state-of-the-art facility in Galway.


Responsibilities:

• Responsible for the implementation of PMS activities identified under as defined in relevant Quality System procedures and Work Instructions.
• Support and lead Regulatory Post Market System improvements.
• Participate in the implementation of Field Safety Corrective Action plan and associated activities.
• Manage RA activities for Design Changes and Supplier-related changes including reporting assessment and generation of regulatory submissions.
• Provide RA Support to relevant Design Teams for Key Projects identified by Veryan.
• Provide support to other RA Specialists in achieving success for the team.
• Support Gap Assessment process and associated process improvements.
• Provide support in onboarding new territories and re-registration activities in approved territories.
• Support of PMA Annual Periodic Reporting system and approval of annual documentation for submission to FDA.
• Review and approval of RA QMS procedures and work instructions and ensure activities are performed in line with these.
• Implement Technical File for updates arising from changes.
• Identify and awareness of new regulation requirements or changes required to be considered by Veryan Medical for regulatory compliance in all territories for post-market activities.
• Other RA activities, identified on the job, as required.

• Bachelor’s degree (Level 8 NFQ) or relevant Diploma in Engineering/Science or related discipline.
• A minimum of 3 years’ relevant experience in the medical device or pharmaceutical industry is required.
• Experience in Regulatory Affairs/Quality Assurance is preferred.