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
Senior R&D Engineer II
Galway
Product Development Engineer
Galway
Design Assurance Engineer
Galway
Senior R&D Engineer
Galway
Process Chemist
Limerick
Senior R&D Engineer
Dublin
Territory Manager (Endoscopy)
Dublin
R&D Engineer
Galway
Senior Research and Development Engineer
Galway
Principal R&D Engineer
Galway
(Senior) Manufacturing Engineers - Globa
Limerick
Senior R&D Manager - Lifecycle Manag
Galway
R&D Manager
Galway
Quality Technician
Galway
Design Quality Engineer
Galway
EHSS Specialist
Athlone
Production Operator
Meath
Product Development Engineer II
Athlone
Marketing Manager
Galway
Project Manager
Kildare
Staff Systems Engineer
Limerick
Principal R&D Engineer
Galway
Product Development Manager
Galway
Construction Manager - Pharma/Biotech
Dublin
Application Software Engineer
Galway
Microbiology Manager
Dublin
Project Engineer
Clare
Senior R&D Manager - Lifecycle Manag
Galway
Senior QC Associate (Bioassay)
Dublin
Regulatory Affairs Manager - Senior
Galway
Senior Product Development Engineer
Galway
Tech Transfer Lead - Sterile Drug Produc
Dublin
Validation Engineer
Dublin
Senior Project Manager - Contract Develo
Dublin
Injection Moulding Engineer
Athlone
EHS Specialist II
Limerick
Process Engineer - Sterile Drug Product
Waterford
Senior Design Assurance Engineer
Galway
Quality Manager
Dublin
Quality Assurance Specialist
Carlow
Senior Production Manager
Cork
R&D Engineer
Galway
Principal Process Equipment Engineer
Dublin South
Senior Clinical Data Analyst
Dublin
Responsible Person (RP)
Republic of Ireland
Senior Electrical Engineer
Galway
Quality Manager
Galway
Senior Mechanical Engineer
Dublin
Operations Engineer
Galway
Senior Quality Systems Engineer
Galway
Clinical Applications Specialist (Surgic
Belfast City
Senior QC Specialist
Dublin
Design Assurance Engineer
Galway
Advanced Technologies R&D Manager
Clare
Quality Assurance Specialist/Manager
Dublin
Principal Reliability Engineer
Galway
Senior R&D Engineer-New Product Deve
Westmeath
Senior Manufacting Engineer
Republic of Ireland
Senior Quality Engineer
Galway
R&D Senior Program Manager
Galway
QA Manager
Canada
R&D Lifecycle Manager
Connaught
Senior Human Factors Engineer
Galway
R&D Engineer
Galway
Injection Moulding Engineer
Leitrim
R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Utilities Engineer
Dublin
Inside Scientific Sales Specialist
Dublin
Quality Specialist
Tipperary
Senior Engineering Manager
Galway
Senior Reg Affairs Specialist - Post Mar
Galway
Senior Product Development Engineer
Galway
Senior Engineering Manager
Limerick
Senior Manufacturing Engineer
Galway
A.I Specialist
Clare
R&D Engineer
Dublin
Bioinformatician
Dublin
Manufacturing Technician
Clare
Continuous Improvement Specialist
Dublin
Quality Engineer
Athlone
Senior Commissioning & Qualification
Roscommon
Senior Project Engineer
Cavan
Product Specialist (Critical Care &
Dublin
Head of Data Partnerships & Operatio
Dublin
Senior Product Development Engineer
Galway
Senior Design Engineer
Dublin
R&D Engineer
Galway
Product Development Engineer II
Athlone
Calibration Technician
Republic of Ireland
Quality Engineer
Galway
Scientific Officer- Virology
Dublin
Senior QC Analyst
Republic of Ireland
Black Utilities Engineer
Westmeath
Quality Assurance Specialist (hybrid)
Dublin
CQV Engineer
Roscommon
Senior QA Associate (shift)
Dublin
Senior Sterile Drug Product MSAT Consult
Republic of Ireland
Injection Moulding Engineer
Athlone
Senior Regulatory Affairs Specialist
Athlone
Industrial Designer
Galway
Quality Manager
Galway
Process Development Engineer
Galway
Senior Equipment Design Engineer
Dublin
Senior Equipment Engineer
Dublin
Quality Engineer - Supplier
Galway
Senior Quality Engineer
Dublin
Quality Assurance Specialist
Waterford
Supplier Quality Engineer
Galway
Senior R&D Engineer
Galway
Process Scientist MSAT
Louth
Product Specialist (Critical Care &
Dublin
Senior Process Engineer
Longford
R&D Director
Galway
Warehouse Operator
Dublin
Project Manager
Galway
Project Engineer - Senior
Cavan
Product Development Engineer
Dublin
Project Engineer
Cork
Senior Operational Readiness Associate
Dublin
QC Specialist
Clare
Senior R&D Engineer
Galway
Advanced Technologies Manager
Galway
R&D Manager
Connaught
Documentation Specialist
Louth
LIMS Specialist
Tipperary
Documentation Specialist
Louth
Production Manager
Dublin
Principal R&D Engineer
Galway
QA Engineer
Leitrim
QA Deviations Specialist
Dublin
Senior Associate Quality Control
Dublin
QC Microbiology Manager
Dublin
Biomedical Engineer
Dublin
Key Account Manager - Retail UK National
South East
Design Assurance Manager
Galway
R&D Engineer
Clare
Quality Assurance Team Lead
Cork
Strategic Automation Lead
Waterford
R&D Engineer
Galway
Quality Manager
Galway
Senior Quality Assurance Engineer
Galway
R&D Manager
Athlone
Laboratory Systems Specialist
Meath
Senior Quality Engineer
Dublin
Senior Quality Assurance Associate
Dublin
Principal Engineer
Dublin
Senior Equipment Design Engineer
Dublin
Quality Control Analyst (Cell Culture)
Carlow
Senior Engineering Manager
Galway
Manufacturing Technician
Clare
R&D Engineer
Galway
Manufacturing Technician
Clare
UK Based-EAP Program Manager-Remote
United Kingdom
Senior Clinical Data Analyst
Dublin
EAP Program Manager
Republic of Ireland
Senior Electronics Engineer
Dublin
Quality Assurance Associate
Cork
Process Engineer
Leitrim
Project Manager - R&D
Galway
Senior Quality Engineer
Galway
R&D Director
Galway
Principal Device Engineer
Dublin
R&D Manager
Athlone
Senior Quality Systems Engineer
Galway
Senior Clinical Data Analyst
Dublin
Director of Regulatory Affairs
Galway
Purchasing Manager
Waterford
Senior Quality Engineer
Dublin
Quality Assurance Specialist
Carlow
Shift Technician (Injection Moulding)
Kildare
Scientific Operations Manager & PMO
Dublin
R&D Engineer
Galway
Distribution Partner Manager (Life Scien
Dublin
Senior QC Associate - Equipment & I
Dublin
Sr Principal R&D Engineer
Galway
Senior R&D Engineer
Galway
Project Manager
Kildare
Senior Regulatory Affairs Specialist
Westmeath
Senior Quality Engineer
Galway
Laboratory Technician (Microbiology &
Dublin
Clinical Sales Specialist (Histology)
Dublin
R&D Engineer
Dublin
Lead MSAT Validation Consultant
Republic of Ireland
R&D Engineer
Galway
Senior Manufacturing Engineer
Galway City
R&D Manager
Dublin
Supply Chain Specialist - New Material I
Meath
Business Development Manager
Republic of Ireland
Validation Engineer Intermediate
Dublin
R&D Manager
Galway
Senior Process Engineer - DP or DS
Dublin
Quality Technician
Dublin
Operations Manager
Galway
Senior Design Assurance Engineer
Galway
Senior Supplier Engagement Manager
Dublin
Director of R&D
Limerick
Senior Maintenance Technician
Kilkenny
Senior QC Specialist - Equipment & I
Dublin
Head of Digital & Technology
Dublin
Quality Assurance Manager
Galway
Senior R&D Engineer
Dublin
R&D Manager
Galway
Documentation Specialist
Louth
Quality Specialist
Clare
R&D Director
Galway
CTO
Galway
Senior Manufacturing Engineer
Cork
Principal R&D Engineer
Galway
Business Manager (Woundcare, Orthopaedic
Dublin
Senior Process Development Engineer
Galway
CTO
Dublin
Senior Quality Engineer
Dublin
Design Assurance Engineer
Galway
Senior Quality Engineer
Dublin
R&D Manager
Connaught
Senior Project Engineer - R&D
Galway
Senior Electronic Engineer
Dublin
R&D Manager
Galway
Senior Product Development Engineer
Galway
Quality Engineer - Supplier
Galway
R&D Manager
Galway
Design Assurance Program Manager
Galway
R&D Engineer
Galway
Senior Electronic Engineer
Limerick
Senior R&D Engineer
Galway
Manufacturing Specialist (Investigation
Dublin
Principal R&D Engineer
Dublin
Manufacturing Engineer
Galway
Senior Design Assurance Engineer
Galway
Manufacturing Technician
Clare
Senior Quality Assurance Technical Suppo
Dublin
Product Development Engineer
Galway
Supply Chain Project Manager (hybrid)
Dublin
Quality Engineer
Athlone
R&D Manager
Connaught
Senior R&D Engineer
Galway
Mechanical Technician
Carlow
Validation & Verification Engineer
Dublin
Senior Regulatory Affairs Specialist
Dublin
Senior Project Manager
Meath
Senior Regulatory Affairs Specialist
Clare
Senior Operations Engineer
Galway
Senior Electronic Engineer
Dublin
Quality Engineer - Supplier
Galway
R&D Manager
Connaught
Quality Manager
Galway
Senior Design Engineer
Dublin
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]