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
Engineering Business Manager
Dublin
R&D Engineer
Clare
Principal Design and Development Enginee
Galway
Quality Technician
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Design Assurance Engineer
Galway
Senior R&D Engineer
Galway
Quality Specialist (hybrid)
Tipperary
Electronic Engineer
Dublin
QA Manager
Canada
Project Engineer
Republic of Ireland
Senior R&D Engineer
Galway
R&D Director
Galway
Senior Maintenance Technician
Roscommon
Electrical Technician
Limerick
Product Development Manager
Galway
Responsible Person (RP)
Republic of Ireland
Senior Regulatory Specialist
Cork
Design Assurance Program Manager
Galway
CTO
Dublin
Mechanical Technician
Carlow
Technical Life Cycle & Engineering M
Galway
Project Engineer
Clare
Team Lead - QC Microbiology
Cork
R&D Engineer
Galway
R&D Manager
Connaught
Senior Quality Engineer
Dublin
Senior Research and Development Engineer
Galway
Quality Engineer
Galway
Advanced Technologies Manager
Galway
Supply Chain Project Manager (hybrid)
Dublin
R&D Director
Galway
Product Development Engineer
Dublin
Senior Design Assurance Engineer
Galway
Quality Engineer
Athlone
Documentation Specialist
Louth
Project Manager
Kildare
Documentation Specialist
Louth
R&D Engineer
Galway
Design Assurance Program Manager
Galway
Electronic Engineer
Dublin
Purchasing & Planning Manager
Wexford
R&D Engineer
Dublin
Validation Engineer
Republic of Ireland
Quality Engineer
Galway
Senior R&D Manager
Athlone
Quality Engineer
Galway
Director Engineering & Supply Chain
Galway
Project Manager - R&D
Galway
Project Engineer
Cork
Quality Engineer
Galway
Senior Quality Engineer
Leitrim
R&D Engineer
Galway
Senior QC Associate - Data Analytics
Dublin
R&D Manager
Connaught
Senior Manufacting Engineer
Republic of Ireland
Senior Regulatory Affairs Specialist
Westmeath
Principal R&D Engineer
Galway
Maintenance & Reliability Technician
Limerick
R&D Lifecycle Manager
Connaught
Manufacturing Technician
Clare
Warehouse Operator
Meath
Senior Principal R&D Engineer
Galway
Director of Regulatory Affairs
Galway
Senior R&D Engineer
Dublin
Senior Quality Engineer
Dublin
Director of R&D
Limerick
Design Assurance Engineer
Clare
Quality Technician
Dublin
Health & Safety Specialist
Dublin
Senior Design Assurance Engineer
Galway
Senior Quality Engineer
Dublin
Business Development Manager (Pharma &am
Republic of Ireland
R&D Technician
Galway
Senior R&D Engineer
Galway
Project Manager
Galway
Quality Manager
Galway
Quality Systems Manager
Dublin
Senior Quality Engineer
Dublin
R&D Engineer
Galway
Senior Project Engineer
Cavan
Mechanical Engineer
Dublin
Learning Systems Lead
Limerick
Sales Manager (Healthcare)
Dublin
Advanced Technologies R&D Manager
Clare
Senior R&D Engineer
Galway
Senior R&D Engineer
Galway
Senior R&D Engineer
Clare
Quality Manager
Galway
Quality Technician
Dublin
Product Development Engineer II
Athlone
R&D Manager
Galway
Project Manager - R&D
Galway
Quality Assurance Specialist (hybrid)
Dublin
Quality Specialist
Tipperary
Process Chemist
Limerick
Project Manager (hybrid)
Dublin
Industrial Designer
Galway
Product Development Technician II
Galway
Quality Specialist
Clare
R&D Manager
Athlone
Design Assurance Engineer
Galway
Senior R&D Engineer
Galway
Clinical Seating Specialist - Primary Ca
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Electronic Engineer
Dublin
R&D Manager
Galway
Senior R&D Engineer
Galway
Senior Equipment Design Engineer
Dublin
Engineering Manager
Galway
R&D Engineer
Galway
R&D Engineer
Dublin
R&D Manager
Connaught
Executive Assistant
Meath
Quality Engineer
Galway
Validation Engineer
Carlow
R&D Director
Galway
Senior Automation Engineer
Dublin
R&D Manager
Galway
Senior Regulatory Affairs Manager
Galway
QA Engineer
Leitrim
Senior R&D Engineer
Galway
Injection Moulding Engineer
Leitrim
Senior R&D Engineer
Galway
Quality Engineer
Athlone
Manufacturing Technician
Clare
Injection Molding Engineer
North Leinster
Process Engineer Specialist
Carlow
Senior R&D Engineer
Galway
Senior QC Technical Services - Equipment
Dublin
Engineering Support Specialist
Louth
Continuous Improvement Coach
Limerick
R&D Engineer
Galway
Principal Engineer
Dublin
Supplier Quality Engineer
Galway
Reg Affairs Specialist
Connaught
Technical Life Cycle & Engineering M
Galway
Senior Quality Systems Engineer
Galway
Electrical Condition Monitoring Technici
Limerick
Senior R&D Engineer
Dublin
Quality Manager
Dublin
Principal R&D Engineer
Galway City
Senior Quality Systems Engineer
Galway
Engineering Shift Technician
Dublin
Senior Product Development Engineer
Galway
Manufacturing Technician
Clare
Process Engineer
Galway
R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Regulatory Specialist
Galway
Senior R&D Engineer-New Product Deve
Westmeath
Electronic Engineer
Dublin
R&D Senior Program Manager
Galway
Operations Engineer
Galway
CTO
Galway
Principal R&D Engineer
Galway
Product Specialist (Endoscopy)
Dublin
Technical Marketing Manager
Wexford
R&D Manager
Galway
Senior Regulatory Affairs Manager
Galway
Principal R&D Engineer
Galway
Principal Engineer
Dublin
Process Development Engineer
Galway
Senior Product Development Engineer
Galway
Senior Electronics Engineer
Dublin
Senior Regulatroy Affairs Specialsit
Galway
Principal Device Engineer
Dublin
R&D Manager
Connaught
Electronic Engineer
Dublin
R&D Program Manager
Dublin
Senior Operations Engineer
Galway
Strategic Automation Lead
Waterford
Senior Electronic Engineer
Dublin
Senior Product Development Engineer
Galway
Senior Electronic Engineer
Dublin
Senior R&D Engineer
Galway
Regulatory Affairs Maanger
Galway
Senior Regulatory Affairs Specialist
Athlone
Quality Assurance Senior Specialist
Louth
Regulatory Affairs Specialist
Cork
Principal Software Engineer
Athlone
Quality Engineer
Galway
Senior Project Engineer
Cavan
Senior Quality Engineer
Leitrim
Senior R&D Engineer
Galway
Quality Manager
Galway
Project Manager Design Assurance
Galway
Senior Regulatory Specialist
Cork
R&D Engineer
Galway
Senior R&D Engineer
Dublin
Senior R&D Engineer II
Galway
Senior R&D Engineer
Galway
Cleaning Validation Engineer
Republic of Ireland
Senior R&D Engineer
Galway
Pharmacovigilance Manager (Remote)
Republic of Ireland
Project Manager
Kildare
R&D Engineer
Galway
R&D Director
Galway
Senior Process Development Engineer
Galway
Senior Quality Assurance Specialist (hyb
Dublin
Senior Process Engineer
Longford
Manufacturing Engineer
Galway
Senior Regulatory Affairs Specialist
Clare
Quality Assurance Specialist (hybrid)
Dublin
Engineering Support Specialist
Louth
Principal R&D Engineer
Galway
Calibration Technician
Republic of Ireland
Senior Project Engineer
Dublin
R&D Manager
Galway
R&D Engineer
Galway
Quality Engineer
Athlone
Senior Quality Engineer
Leitrim
Quality Assurance Team Lead
Cork
Quality Assurance Team Lead
Cork
R&D Engineer
Galway
Senior Design Engineer
Dublin
Senior R&D Engineer
Galway
Senior Validation Engineer - HVAC
Dublin
R&D Manager
Athlone
Project Engineer
Roscommon
Warehouse Operator
Meath
Sales/Customer Service Administrator
Clonmel
Senior Quality Engineer
Galway
R&D Manager
Dublin
Quality Specialist
Clare
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

Regulatory Specialist


Reference:TG - RA - Galway Location: Galway
Galway City
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA RA Engineer, Regulatory Affairs, Regulatory Affairs Clinical Research, Regulatory Affairs Consultant, Regulatory Affairs Executive, Regulatory Affairs Specialist

Title: Regulatory Specialist
Location: Galway business park, Galway
Benefits: Salary, bonus, pension, hybrid working and healthcare

Overview:
As a Regulatory Specialist you will support the commercialisation of Medical Device products. This includes preparation and submission of regulatory filings for product market entry, as well as regulatory activities required for the maintenance of existing commercial products. The position requires a high level of innovative thought and problem-solving skills. In order to coordinate the variety of regulatory related tasks, the role requires a high degree of flexibility, and structured time and task management


Responsibilities:
- Contribute to the preparation, review and filing of 510(k) submissions to the FDA for both pre-commercial and commercial products
- Prepare and coordinate CE mark submissions/change notifications and Notified Body interactions.
- Maintain Technical Documentation according to the requirements of the Medical Device Regulation.
- Submit and maintain filings on US and EU regulatory databases (eg FURLS, EUDAMED)
- Provide input to the Change Control process for design, manufacturing, and specification changes to assess impact on regulatory compliance and requirements.
- Assist in the development and maintenance of device labelling and IFUs to help ensure they comply with regional regulatory requirements
- Represent Regulatory Affairs within project teams to provide direction.
- Provide regulatory input to customer complaint investigations.
- Support post-market surveillance and vigilance activities, including submission of adverse event reports.


Requirements:

  • Degree in Engineering or Science discipline
  • Minimum of 2 years’ experience in the medical device industry
  • Understanding of FDA and/or MDR requirements, with the ability to interpret and implement these requirements
  • Strong technical aptitude with an ability to analyse and challenge data, identify and address gaps, and generate technical reports to support submissions
  • Self-motivated and clear minded approach to regulatory activities


Does this sound like your next career move? To apply and for more info forward your application