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
Quality Specialist
Clare
Senior Principal R&D Engineer
Galway
Pharmacovigilance Manager (Remote)
Republic of Ireland
Engineering Support Specialist
Louth
Process Development Engineer
Galway
Senior Manufacting Engineer
Republic of Ireland
Regulatory Affairs Specialist
Cork
Senior Design Assurance Engineer
Galway
Quality Engineer
Galway
Inside Sales Representative (IVD Divisio
Kildare
Product Development Engineer II
Athlone
Team Lead - QC Microbiology
Cork
Sterilisation Manager
Tipperary
Senior Regulatroy Affairs Specialsit
Galway
R&D Engineer
Galway
R&D Manager
Connaught
Business Excellence Lead (Manufacturing)
Wexford
Senior Equipment Design Engineer
Dublin
Senior Quality Engineer
Dublin
Senior Associate Quality Control
Dublin
Director of R&D
Clare
Product Development Technician II
Galway
Project Manager Design Assurance
Galway
Quality Engineer
Galway
R&D Engineer
Galway
R&D Manager
Galway
Principal Design and Development Enginee
Galway
R&D Manager
Galway
Senior Regulatory Affairs Specialist
Athlone
Quality Manager
Galway
Project Manager - R&D
Galway
R&D Engineer
Galway
Senior R&D Engineer
Galway
Senior Quality Engineer
Dublin
R&D Engineer
Galway
Senior Maintenance Technician
Roscommon
Project Manager (hybrid)
Dublin
Electronic Engineer
Dublin
Engineering Shift Technician
Dublin
QC Instrumentation Specialist
Dublin
Senior R&D Engineer
Galway
Advanced Technologies Manager
Galway
Engineering Support Specialist
Louth
Analytical Chemist
Tipperary
Electronic Engineer
Dublin
Quality Specialist
Clare
Project Manager - R&D
Galway
Project Manager
Galway
Director of R&D
Clare
Process Chemist
Limerick
Electronic Engineer
Dublin
Project Manager
Kildare
Design Assurance Engineer
Galway
Mechanical Engineer
Dublin
Senior R&D Engineer-New Product Deve
Westmeath
Principal R&D Engineer
Dublin
Injection Molding Engineer
North Leinster
CTO
Galway
Injection Moulding Engineer
Athlone
Senior Regulatory Specialist
Cork
(Senior) Manufacturing Engineers - Globa
Limerick
Senior Equipment Design Engineer
Dublin
Engineering Business Manager
Dublin
Director of R&D
Limerick
Project Engineer
Republic of Ireland
Quality Engineer
Galway
Technical Support Specialist - Drug Subs
Louth
Product Development Engineer
Galway
Senior Research & Development Engine
Limerick
Injection Molding Engineer
North Leinster
Senior Regulatory Affairs Specialist
Athlone
Senior Electronic Engineer
Dublin
Principal Quality Engineer
Galway
Senior Engineering Manager
Limerick
Design Assurance Program Manager
Galway
Senior R&D Engineer
Galway
Manufacturing Technician
Clare
Senior R&D Engineer
Galway
Business Development Manager (Pharma &am
Republic of Ireland
R&D Manager
Galway
Senior QC Associate
Dublin
Senior Electronic Engineer
Dublin
Manufacturing Engineer
Galway
Electronic Engineering
Dublin
Senior Project Engineer
Dublin
Documentation Specialist
Louth
R&D Engineer
Galway
Operations Engineer
Galway
Electrical Technician
Limerick
R&D Director
Galway
Senior QC Technical Services - Equipment
Dublin
Electronic Engineer
Dublin
Senior R&D Engineer
Galway
R&D Manager
Connaught
Quality Engineer
Galway
Senior R&D Engineer
Galway
Quality Engineer
Athlone
Quality Engineer
Athlone
Senior R&D Engineer
Galway
Quality Engineer
Galway
Senior Regulatory Affairs Manager
Galway
R&D Engineer
Galway
R&D Engineer
Galway
R&D Engineer
Galway
Engineering Manager
Galway
Senior Electrical Engineer
Galway
R&D Manager
Connaught
R&D Manager
Dublin
Senior Regulatory Affairs Specialist
Athlone
Regulatory Affairs Maanger
Galway
R&D Engineer
Galway
Senior Regulatory Affairs
Galway
Injection Moulding Engineer
Athlone
Staff R&D Engineer
Limerick
Senior Microbiologist
Dublin
Senior Electronic Engineer
Dublin
Senior R&D Engineer
Galway
Senior R&D Engineer
Galway
Product Development Engineer
Dublin
Electronic Engineer
Dublin
Maintenance & Reliability Technician
Limerick
Calibration Technician
Republic of Ireland
Quality Manager
Dublin
Senior R&D Engineer
Galway
Cleaning Validation Engineer
Republic of Ireland
Senior Regulatory Affairs Manager
Galway
Manufacturing Technician
Clare
Senior R&D Engineer
Galway
Senior Quality Engineer
Leitrim
Senior R&D Engineer
Galway
Senior Equipment Design Engineer
Dublin
R&D Director
Galway
Senior Design Assurance Engineer
Athlone
R&D Manager
Galway
Senior Operations Engineer
Galway
Principal R&D Engineer
Galway City
Mechanical Technician
Carlow
Senior Project Engineer - R&D
Galway
Product Development Manager
Galway
R&D Manager
Athlone
Manufacturing Technician
Clare
Senior Reg Affairs Specialist - Post Mar
Galway
Industrial Designer
Galway
Senior Principal R&D Engineer
Galway
Quality Assurance Specialist (hybrid)
Dublin
Quality Assurance Team Lead
Cork
Quality Assurance Associate
Cork
R&D Engineer
Galway
Electronic Engineer
Dublin
Quality Engineer
Athlone
Project Manager
Kildare
Quality Specialist
Tipperary
Senior R&D Manager - Lifecycle Manag
Galway
Supply Chain Project Manager (hybrid)
Dublin
Executive Assistant
Meath
Senior Operations Engineer
Galway
Injection Molding Engineer
North Leinster
R&D Engineer
Dublin
Senior Quality Engineer
Dublin
Quality Specialist
Clare
Medical Officer,Centralised and Clinical
Dublin
Electronic Engineer
Dublin
Quality Specialist (hybrid)
Tipperary
QC Bioanalytical Sciences - Senior Assoc
Dublin
R&D Manager
Athlone
Senior Regulatory Affairs Specialist
Dublin
Senior R&D Engineer
Galway
R&D Engineer
Clare
Senior Quality Assurance Specialist
Cork
Senior Maintenance Technician
Kilkenny
Principal Software Engineer
Athlone
Warehouse Operator
Meath
Senior Quality Engineer
Galway
Quality Engineer
Galway
CTO
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Quality Assurance Team Lead
Cork
Senior Automation Engineer
Dublin
Quality Assurance Specialist (shift)
Carlow
Quality Assurance Specialist/Manager
Dublin
Senior R&D Engineer
Clare
Application Software Engineer
Galway
Senior Quality Engineer
Leitrim
Quality Assurance Specialist (Logistics)
Dublin
R&D Manager
Connaught
Injection Moulding Engineer
Athlone
Senior Associate Quality Control (Shift)
Dublin
Biomedical Engineer
Dublin
R&D Engineer
Dublin
Sales/Customer Service Administrator
Clonmel
Senior R&D Engineer
Galway
Reg Affairs Specialist
Connaught
Manufacturing Technician
Clare
Technical Life Cycle & Engineering M
Galway
Senior Process Engineer
Longford
Graduate Occupational Hygiene Consultant
Kildare
Senior Principal R&D Engineer
Galway
Senior R&D Engineer
Galway
Regulatory Affairs Manager - Senior
Galway
Production Operator
Meath
Continuous Improvement Coach
Limerick
Quality Manager
Dublin
Product Specialist (Endoscopy)
Dublin
Senior Regulatory Affairs Specialist
Athlone
Clinical Seating Specialist - Primary Ca
Dublin
Product Development Engineer II
Athlone
Engineering Manager
Galway
Senior R&D Engineer
Galway
Principal R&D Engineer
Galway
R&D Engineer
Galway
Supplier Quality Engineer
Galway
Embedded Software Engineer
Dublin
Senior Project Engineer
Cavan
Senior R&D Engineer
Dublin
Quality Assurance Specialist (shift)
Carlow
Senior R&D Manager - Lifecycle Manag
Galway
Analytical Chemist
Tipperary
Senior Principal Design and Development
Galway
QA Manager
Canada
Advanced Technologies R&D Manager
Clare
Project Manager - R&D
Galway
Responsible Person (RP)
Republic of Ireland
Documentation Specialist
Louth
Validation Engineer
Republic of Ireland
Production Manager
Dublin
Quality Technician
Dublin
Senior Product Development Engineer
Galway
QA Engineer
Leitrim
Senior R&D Engineer
Galway
R&D Director
Galway
R&D Manager
Galway
Quality Specialist - Quality Management
Dublin
Senior QC Associate (Bioassay)
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

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