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
Biomedical Engineer
Dublin
R&D Manager
Connaught
Quality Assurance Specialist
Carlow
R&D Engineer
Galway
Documentation Specialist
Louth
R&D Engineer
Galway
Project Engineer
Cork
EHSS Specialist (Construction & Comm
Athlone
Director of R&D
Limerick
QC Microbiology Manager
Dublin
R&D Engineer
Dublin
Senior Design Assurance Engineer
Galway
(Senior) Manufacturing Engineers - Globa
Limerick
Senior Operations Engineer
Galway
Project Engineer
Roscommon
Senior Quality Engineer
Dublin
R&D Manager
Galway
Senior Maintenance Technician
Kilkenny
Senior Operational Readiness Associate
Dublin
Quality and Regulatory Affairs Manager
Dublin
Senior QC Microbiology
Dublin
Project Engineer
Clare
Tech Transfer Lead
Dublin
Electronic Engineering
Dublin
Quality Manager
Galway
R&D Manager
Galway
Quality System & Regulatory Affairs
Galway
Senior Associate Data Analytics
Dublin
Senior Regulatory Affairs Specialist
Athlone
Senior Process Engineer
Dublin
Lead MSAT Validation Consultant
Republic of Ireland
Software Design Assurance Engineer
Dublin
Quality Manager
Dublin
Senior QC Specialist - Equipment & I
Dublin
Advanced Technologies Manager
Galway
Senior Engineering Manager
Galway
R&D Engineer II
Galway
Quality Manager
Galway
Senior QA Associate (shift)
Dublin
CAPEX API Project Manager
Tipperary
Senior Quality Systems Engineer
Galway
Senior Project Engineer
Cavan
Proposal Manager
Dublin
Operational Excellence Lead
Dublin
Senior Operations Engineer
Galway
R&D Engineer
Galway
Manufacturing Specialist
Dublin
R&D Engineer
Dublin
Quality Technician
Galway
Senior Quality Engineer
Galway
Utilities Engineer
Dublin
Senior R&D Engineer
Galway
Injection Moulding Engineer
Athlone
R&D Engineer II
Galway
R&D Manager
Connaught
Senior R&D Manager - Lifecycle Manag
Galway
Senior Mechanical Engineer
Dublin
Principal R&D Engineer
Galway
Senior R&D Engineer
Galway
R&D Manager
Athlone
R&D Manager
Galway
Senior Design Assurance Engineer
Galway
Manufacturing Technician
Clare
Lead OSD Process Engineer
Westmeath
Product Development Engineer II
Athlone
Graduate Occupational Hygiene Consultant
Kildare
Production Operator
Meath
Learning Systems Lead
Limerick
Senior QC Associate - Micro
Dublin
Senior Product Development Engineer
Galway
Senior R&D Engineer
Galway
Senior Quality Control Associate
Dublin South
Part time QP
Dublin
Product Development Technician II
Galway
Senior Manufacturing Engineer
Cork
Engineering Shift Technician
Dublin
Sales Specialist (Life Sciences)
Dublin
Senior Project Engineer
Cork
Documentation Specialist
Louth
Senior Design Engineer
Dublin
R&D Engineer
Galway
Injection Moulding Engineer
Athlone
Engineering Business Manager
Dublin
Senior R&D Manager
Athlone
Manufacturing Technician
Galway
LIMS Specialist
Tipperary
QC Operations Lead
Louth
Process Engineer
Galway
Senior Product Development Manager
Galway
Senior Project Manager
Meath
R&D Technician
Galway
Senior Engineering Manager
Galway
Principal Process Equipment Engineer
Dublin South
Senior Manufacturing Engineer
Galway
Senior R&D Engineer
Limerick
Quality Manager - Medical Devices
Limerick City
A.I Specialist
Clare
Warehouse Operator
Dublin
NPI Engineer - Hybrid
Dublin
Director of Regulatory Affairs
Galway
Quality Engineer - Supplier
Galway
R&D Engineer II
Galway
Design Assurance Manager
Galway
Supply Chain Project Manager (hybrid)
Dublin
Senior Regulatory Affairs Specialist
Athlone
Laboratory Systems Specialist
Meath
Regulatory Affairs Manager - Senior
Galway
Product Specialist (Critical Care &
Dublin
Contract Development & Manufacturing
Dublin
Process Engineer
Leitrim
Principal R&D Engineer
Galway
Process Chemist
Limerick
Senior R&D Engineer
Galway
Project Manager
Kildare
Manufacturing Specialist (Investigation
Dublin
Supplier Quality Engineer
Galway
R&D Engineer
Galway
Senior Manufacting Engineer
Republic of Ireland
R&D Director
Galway
Equipment Engineer (Syringe filling)
Dublin
Head of Data Partnerships & Operatio
Dublin
Senior R&D Engineer
Limerick
Business Development Manager (Hospitals)
Cork
QC Microbiology Technician
Kildare
Senior R&D Engineer
Dublin
QA Manager
Canada
Product Specialist (Critical Care &
Dublin
Project Manager
Kildare
Senior Technology Transfer Specialist
Dublin
Senior Maintenance Technician
Roscommon
Director of R&D
Clare
Quality Assurance Engineer
Longford
CTO
Galway
Principal Engineer
Dublin
Manufacturing Technician
Clare
Senior Quality Assurance Associate
Dublin
Responsible Person (RP)
Republic of Ireland
Senior Regulatroy Affairs Specialsit
Galway
Design Assurance Engineer
Galway
QC Specialist
Clare
Head of Data Partnerships & Operatio
Dublin
Project Manager - R&D
Galway
Instrumentation Engineer
Meath
R&D Manager
Connaught
Project Manager
Dublin
Senior R&D Engineer
Galway
R&D Engineer
Galway
Senior Product Development Engineer
Galway
Senior R&D Engineer
Galway
Quality Systems Specialist
Tipperary
Customer Care and Sales Support Assistan
Dublin
Warehouse Systems Specialist
Cork
Quality Assurance Manager
Galway
R&D Engineer
Clare
Senior Product Development Engineer
Galway
Quality Assurance Specialist/Manager
Dublin
Senior Regulatory Affairs Specialist
Westmeath
Project Manager - New Product Introducti
Dublin
Distribution Partner Manager (Life Scien
Dublin
Senior Product Development Engineer
Galway
Senior Quality Engineer
Leitrim
Senior Regulatory Affairs Specialist
Athlone
Senior Regulatory Affairs
Galway
Senior Project Engineer - R&D
Galway
Shift Technician (Injection Moulding)
Kildare
Quality Assurance Specialist (Hybrid)
Dublin
Product Development Engineer
Galway
Operations Engineer
Galway
Quality Manager
Dublin
Senior R&D Engineer
Galway
Senior QC Technical Services Specialist
Dublin
Clinical Advisor - Wound care (Part-time
Dublin
QA Specialist
Carlow
Quality Assurance Specialist (hybrid)
Dublin
R&D Engineer
Galway
Senior QC Microbiology
Dublin
Senior Quality Engineer
Leitrim
Product Development Technician II
Galway
Manufacturing Technician
Galway
R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Clare
Senior Electronics Engineer
Dublin
Quality Technician
Dublin
Quality Assurance Team Lead
Cork
Senior R&D Engineer
Clare
Validation & Verification Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
R&D Engineer
Galway
Senior Research and Development Engineer
Galway
CTO
Dublin
Regulatory Affairs Manager- Remote
Republic of Ireland
Manufacturing Technician - Balloons
Galway
Calibration Technician
Republic of Ireland
R&D Engineer
Galway
Laboratory Technician (Microbiology &
Dublin
Senior Quality Engineer
Dublin
Senior Equipment Design Engineer
Dublin
Senior Specialist MS&T
Dublin
Design Assurance Program Manager
Galway
Quality Specialist
Tipperary
Quality Engineer
Wexford
Microbiology Manager
Dublin
Injection Molding Engineer
Mayo
R&D Director
Galway
Production Manager
Wexford
CQV Engineer
Roscommon
Senior Equipment Design Engineer
Dublin
Principal Software Engineer
Athlone
Senior R&D Engineer
Galway
Clinical Sales Specialist (Histology)
Dublin
Senior R&D Manager
Athlone
R&D Manager
Athlone
Senior Principal Design and Development
Galway
Senior R&D Engineer
Galway
QA Engineer
Leitrim
Senior Regulatory Affairs Specialist
Athlone
Process Development Engineer
Galway
Senior Process Engineer
Longford
Clinical Applications Specialist (Surgic
Belfast City
Senior QC Analyst
Republic of Ireland
R&D Manager
Galway
Senior Microbiologist
Dublin
Quality Engineer
Galway
Principal Design and Development Enginee
Galway
Senior Project Engineer - Utilities Syst
Donegal
EAP Portfolio Manager
Republic of Ireland
Production Planner
Kildare
Senior Electronic Engineer
Dublin
Director of R&D
Galway
Dental Consultant- Manager/ Senior Manag
Republic of Ireland
Senior Design Assurance Engineer
Galway
Senior QC Associate - Equipment & I
Dublin
Program Manager
Galway
Principal Reliability Engineer
Galway
Senior Design Engineer
Dublin
R&D Manager
Dublin
A.I Specialist
Galway
Quality Assurance Team Lead
Cork
Senior Quality Assurance Engineer
Galway
Product Development Engineer II
Athlone
Business Development Manager
Republic of Ireland
Principal R&D Engineer
Galway
EHSS Specialist
Athlone
Technical Life Cycle & Engineering M
Galway
Quality Engineer
Galway
Product Development Engineer
Galway
Sr Principal R&D Engineer
Galway
Injection Moulding Engineer
Athlone
Strategic Automation Lead
Waterford
Senior Quality Assurance Technical Suppo
Dublin
R&D Manager
Connaught
Senior Process Development Engineer
Dublin
Quality Systems Manager
Dublin
OSD Process Engineer
Westmeath
R&D Director
Galway
Senior Production Manager
Cork
R&D Manager
Galway
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]