I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome		 IE
Internet Explorer		 firefox
Mozilla Firefox		 opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Job Tools
Contact Info
Thomas Gallagher
Life Science

+353870612325
[email protected]
Connect with me on
Hot Science Jobs
Project Manager
Kildare
R&D Manager
Galway
Senior Design Assurance Engineer
Galway
Technical Marketing Manager
Wexford
Senior R&D Manager - Lifecycle Manag
Galway
R&D Manager
Dublin
R&D Scientist (Microbiology)
Wexford
R&D Engineer
Galway
Senior Operations Engineer
Galway
Manufacturing Technician
Clare
Process Development Engineer
Galway
Principal R&D Engineer
Galway City
Senior R&D Engineer
Dublin
Electronic Engineer
Dublin
Regulatory Affairs Associate
Cork
R&D Engineer
Galway
Senior Research & Development Engine
Limerick
R&D Engineer
Clare
Senior Regulatory Affairs Specialist
Westmeath
Principal Design and Development Enginee
Galway
Biomedical Engineer
Dublin
Senior Electronic Engineer - Regulated M
Galway
Mechanical Technician
Carlow
Senior Quality Engineer
Leitrim
R&D Director
Galway
Purchasing & Planning Manager
Wexford
Territory Sales Specialist (Life Science
Belfast City
R&D Manager
Galway
Design Assurance Engineer
Clare
Clinical Research Manager
Cork
Advanced Technologies R&D Manager
Clare
Quality Manager - NPI
Dublin
Advanced Technologies Manager
Galway
Senior Maintenance Technician
Kilkenny
R&D Engineer
Dublin
Senior Project Engineer
Cavan
Senior Quality Engineer
Leitrim
Senior R&D Engineer
Galway
Electronic Engineer
Dublin
R&D Engineer
Galway
Associate Director - Manufacturing &
Limerick
Senior Maintenance Technician
Kilkenny
Electrical Condition Monitoring Technici
Limerick
Principal Software Engineer
Athlone
R&D Manager
Athlone
Quality Assurance Engineer
Longford
Electronic Engineer
Dublin
Quality Specialist
Clare
Manufacturing Technician
Clare
Injection Molding Engineer
North Leinster
Senior Operations Engineer
Galway
Project Manager
Kildare
Senior Quality Engineer
Dublin
Warehouse Operator
Meath
Senior Electronics Engineer
Limerick
Territory Manager (Woundcare)
Cork
Senior Quality Engineer
Dublin
R&D Manager
Athlone
Senior R&D Engineer
Galway
Project Manager Design Assurance
Galway
Quality Assurance Team Lead
Cork
Senior Quality Engineer
Dublin
Shift Technician (Injection Moulding)
Kildare
Quality Assurance Team Lead
Cork
Maintenance & Reliability Technician
Limerick
Embedded Software Engineer
Dublin
Regulatory Affairs Maanger
Galway
Senior R&D Engineer
Galway
Electronic Engineer
Dublin
Quality Engineer
Galway
Quality Control Analyst (shift)
Carlow
Application Software Engineer
Galway
Value Stream Team Leader / Production Su
Wexford
Senior Microbiologist
Dublin
Product Development Engineer
Dublin
Senior Electronic Engineer
Dublin
Senior Quality Systems Engineer
Galway
Senior Product Development Engineer
Galway
Quality Technician
Dublin
Quality Engineer
Galway
R&D Manager
Galway
Software Design Assurance Engineer
Dublin
Senior Reg Affairs Specialist - Post Mar
Galway
Manufacturing Technician
Clare
Principal Instrumentation & Calibrat
Limerick
Purchasing & Planning Manager
Wexford
Senior Manufacturing Engineer
Galway
R&D Engineer
Galway
R&D Engineer
Galway
Quality Assurance Associate
Cork
Continuous Improvement Coach
Limerick
Senior Maintenance Technician
Roscommon
Project Engineer
Clare
Senior Operations Engineer
Galway
Quality Manager
Dublin
Senior Quality Engineer
Dublin
Senior Design Engineer
Dublin
R&D Manager
Connaught
Production Operator
Meath
R&D Engineer
Dublin
Senior R&D Engineer
Galway
Principal R&D Engineer
Dublin
Design Assurance Engineer
Clare
Senior Manufacting Engineer
Republic of Ireland
R&D Technician II
Galway
Senior R&D Engineer
Galway
Quality Specialist
Tipperary
R&D Manager
Galway
CTO
Dublin
Product Development Engineer
Dublin
Electronic Engineer
Dublin
R&D Manager
Connaught
Senior R&D Manager - Lifecycle Manag
Galway
Senior Regulatory Affairs Specialist
Dublin
Electrical Technician
Limerick
Senior Design Assurance Engineer
Athlone
Quality Engineer
Galway
QA Manager
Canada
Calibration Technician
Republic of Ireland
Responsible Person (RP)
Republic of Ireland
R&D Director
Galway
Design Assurance Engineer
Galway
Senior R&D Engineer-New Product Deve
Westmeath
QA Engineer
Leitrim
Electronic Engineer
Dublin
Product Development Engineer
Dublin
Senior Design Assurance Engineer
Galway
Product Specialist (Endoscopy)
Dublin
Senior R&D Engineer
Galway
CTO
Galway
R&D Project Manager
Galway
Injection Moulding Engineer
Athlone
Principal Device Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
QC Bioanalytical Sciences - Senior Assoc
Dublin
Quality Engineer
Galway
Senior Equipment Design Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Mechanical Engineer
Dublin
Principal R&D Engineer
Galway
Electronic Engineer
Dublin
R&D Engineer
Galway
Sales/Customer Service Administrator
Clonmel
Process Engineer
Roscommon
Quality Engineer
Galway
R&D Manager
Connaught
Senior R&D Engineer
Galway
Principal Engineer
Dublin
Regulatory Specialist
Galway
R&D Engineer
Galway
Quality Manager
Galway
Principal R&D Engineer
Galway
Senior Process Development Engineer
Galway
R&D Technician
Galway
Quality Engineer
Galway
Senior Equipment Design Engineer
Dublin
Principal Engineer
Dublin
R&D Director
Galway
R&D Engineer
Galway
Product Development Engineer II
Athlone
Quality Engineer
Galway
Senior Quality Engineer
Leitrim
Process Engineer
Roscommon
Staff Systems Engineer
Limerick
Senior R&D Manager
Athlone
Injection Molding Engineer
North Leinster
Senior R&D Engineer
Galway
R&D Engineer
Galway
Project Manager Design Assurance
Galway
R&D Lifecycle Manager
Connaught
R&D Senior Program Manager
Galway
Microbiology Manager
Dublin
Senior R&D Engineer
Galway
EHS Officer
Dublin
Process Chemist
Limerick
Senior Process Engineer
Galway
Process Engineer
Roscommon
Quality Manager - Medical Devices
Limerick City
Quality Systems Manager
Dublin
Quality Assurance Senior Specialist
Louth
Senior R&D Manager
Athlone
Senior Regulatory Affairs
Galway
Senior Associate Quality Control
Dublin
Business Development Manager (Pharma &am
Republic of Ireland
R&D Engineer
Galway
Technical Transfer Specialist - Remote
Republic of Ireland
R&D Manager
Galway
Senior Regulatory Specialist
Cork
Learning Systems Lead
Limerick
R&D Program Manager
Dublin
Project Manager
Galway
R&D Manager
Connaught
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to [email protected]
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]