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Thomas Gallagher
Life Science

+353870612325
[email protected]
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Details

Reg Affairs Specialist


Reference:TG - RA - Galway Location: Connaught
Galway
Galway City
Leitrim
Limerick
Limerick City
Offaly
Roscommon
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Lead Quality Engineer, QA Engineer, QA RA Engineer, QA Specialist, Quality Specialist, Regulatory Affairs, Regulatory Affairs Clinical Research, Regulatory Affairs Consultant

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.



Education & Training

  • 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.



To apply for more info call me on 087 0612325 or email [email protected]