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
James Cassidy
Life Science

+353 1 5079250
[email protected]
Connect with me on
Hot Science Jobs
R&D Lifecycle Manager
Connaught
Project Manager
Kildare
Director of R&D
Galway
R&D Engineer
Galway
Senior Electronic Engineer
Dublin
R&D Manager
Galway
Regulatory Affairs Maanger
Galway
R&D Manager
Dublin
Graduate Occupational Hygiene Consultant
Kildare
Quality Engineer
Athlone
Electrical Condition Monitoring Technici
Limerick
Senior Process Engineer
Dublin
Senior QC Specialist - Equipment & I
Dublin
Responsible Person (RP)
Republic of Ireland
Key Account Manager - Retail UK National
South East
Manufacturing Engineer
Galway
R&D Engineer
Clare
R&D Manager
Galway
Quality Manager
Galway
Senior Scientist IVD Assay Development
Galway
Senior Process Development Engineer
Galway
CTO
Dublin
Quality Assurance Associate
Cork
Senior Quality Assurance Associate
Dublin
Principal Process Equipment Engineer
Dublin South
Senior Design Engineer
Dublin
Senior Electronic Engineer
Dublin
R&D Engineer
Dublin
CAPEX API Project Manager
Tipperary
Senior Product Development Engineer
Galway
Quality Assurance Specialist/Manager
Dublin
Equipment Engineer (Syringe filling)
Dublin
R&D Manager
Connaught
Senior R&D Engineer
Dublin
Design Assurance Engineer
Galway
Quality Specialist
Tipperary
Senior Operational Readiness Associate
Dublin
Quality Manager - Medical Devices
Limerick City
Senior Clinical Data Analyst
Dublin
Senior Quality Assurance Specialist
Cork
Manufacturing Technician
Clare
Manufacturing Specialist (Investigation
Dublin
Documentation Specialist
Louth
Validation Engineer
Republic of Ireland
Project Manager - R&D
Galway
Project Engineer - Senior
Cavan
Associate Quality Specialist
Tipperary
Calibration Technician
Republic of Ireland
R&D Manager
Connaught
Manufacturing Technician
Clare
Senior Equipment Design Engineer
Dublin
R&D Manager
Galway
Project Manager
Kildare
Industrial Engineer Capacity Planning
Dublin
Senior R&D Engineer
Dublin
Director of Regulatory Affairs
Galway
EHS Specialist II
Limerick
Warehouse Operator
Dublin
Production Manager
Dublin
Product Development Manager
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Senior Regulatory Affairs Specialist
Athlone
Software Design Assurance Engineer
Dublin
Senior Technology Transfer Specialist
Dublin
Sr Principal R&D Engineer
Galway
Senior Equipment Design Engineer
Dublin
R&D Engineer
Galway
R&D Manager
Athlone
Principal R&D Engineer
Dublin
Senior Quality Engineer
Dublin
Business Development Manager
Republic of Ireland
Product Development Engineer
Galway
Senior Quality Systems Engineer
Galway
Senior QC Microbiology
Dublin
Senior Project Engineer
Cavan
Senior Quality Engineer
Dublin
QC Systems Specialist
Dublin
Senior QC Microbiology
Dublin
Senior Equipment Design Engineer
Dublin
Inside Sales Support & Sourcing Spec
Dublin
(Senior) Manufacturing Engineers - Globa
Limerick
Senior Operations Engineer
Galway
R&D Engineer
Galway
Quality Assurance Specialist (shift)
Carlow
Senior Quality Assurance Technical Suppo
Dublin
R&D Manager
Galway
Principal R&D Engineer
Galway
Director of R&D
Clare
Senior Equipment Engineer
Dublin
Senior Quality Engineer
Leitrim
R&D Engineer
Galway
R&D Manager
Athlone
R&D Program Manager
Dublin
Principal Reliability Engineer
Galway
Senior Research and Development Engineer
Galway
Process Chemist
Limerick
Senior Design Assurance Engineer
Galway
Quality Technician
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Senior Quality Engineer
Leitrim
Principal Design Assurance Engineer
Galway
Senior Director of Manufacturing and Sup
Galway
Principal Engineer
Dublin
R&D Engineer
Galway
Quality Assurance Team Lead
Cork
Quality Assurance Specialist
Carlow
Senior Regulatory Affairs
Galway
R&D Director
Galway
Strategic Automation Lead
Waterford
Senior Design Assurance Engineer
Galway
Design Quality Engineer
Galway
Senior Quality Engineer
Galway
Sr Electrical Engineer
Galway
Senior Quality Engineer
Dublin
Strategy Associate Director / Director -
Dublin
Senior Audit & Compliance Specialist
Galway
Senior Regulatory Affairs Specialist
Athlone
QA Deviations Specialist
Dublin
Quality Engineer - Supplier
Galway
R&D Engineer
Galway
Senior Production Manager
Cork
Senior Research and Development Engineer
Galway
QA Manager
Canada
Injection Moulding Engineer
Athlone
Senior QA Specialist
Dublin
Manufacturing Technician
Clare
Quality Manager
Galway
Senior R&D Engineer
Dublin
QA Engineer
Leitrim
Process Engineer
Galway
Product Development Engineer II
Athlone
Supplier Quality Engineer
Galway
Senior Manufacting Engineer
Republic of Ireland
Manufacturing Process Specialist
Dublin
Senior QC Microbiology
Dublin
Director of Regulatory Affairs
Galway
Design Assurance Engineer
Galway
Senior Design Assurance Engineer
Galway
Operations Manager
Galway
Microbiology Manager
Dublin
Senior R&D Engineer
Dublin
Senior R&D Manager
Athlone
Design Assurance Program Manager
Galway
Senior R&D Engineer-New Product Deve
Westmeath
Manufacturing Technician
Clare
Senior QC Associate - Equipment & I
Dublin
Territory Manager (Endoscopy)
Dublin
Senior Microbiologist
Dublin
Senior R&D Engineer
Galway
Product Development Technician II
Galway
Senior Project Engineer - R&D
Galway
Senior Quality Engineer
Leitrim
NPI Engineer - Hybrid
Dublin
Senior Electronic Engineer - Regulated M
Galway
Principal Quality Engineer
Galway
R&D Technician
Galway
Senior QA Associate (shift)
Dublin
Manufacturing Specialist - Investigation
Dublin
Lead MSAT Validation Consultant
Republic of Ireland
Senior QA Specialist
Dublin
Product Development Engineer
Galway
Quality Engineer
Galway
Senior Quality Assurance Associate
Dublin
Principal Engineer
Dublin
Sales Manager (Healthcare)
Dublin
Quality Specialist
Clare
R&D Engineer
Galway
R&D Engineer
Dublin
Regulatory Affairs Manager - Senior
Galway
Product Development Engineer II
Athlone
LIMS Specialist
Tipperary
Senior Regulatory Specialist
Cork
R&D Engineer
Galway
Technical Life Cycle & Engineering M
Galway
Senior Engineering Manager
Limerick
Supply Chain Project Manager (hybrid)
Dublin
Product Development Technician II
Galway
Senior Regulatory Affairs Specialist
Clare
Quality Engineer - Supplier
Galway
Design Assurance Manager
Galway
Senior R&D Engineer
Galway
R&D Engineer
Galway
Environmental Health & Safety (EHS)
Longford
R&D Director
Galway
Senior Reg Affairs Specialist - Post Mar
Galway
Senior R&D Engineer II
Galway
Design Assurance Engineer
Galway
Quality Engineer
Athlone
Industrial Designer
Galway
Senior Product Development Engineer
Galway
Injection Moulding Engineer
Athlone
R&D Director
Galway
R&D Manager
Galway
Senior Regulatory Affairs Specialist
Athlone
Senior Maintenance Technician
Kilkenny
Environmental Health & Safety (EHS)
Longford
Director of R&D
Limerick
Senior Design Assurance Engineer
Galway
Documentation Specialist
Louth
Product Specialist (Critical Care &
Dublin
Injection Moulding Engineer
Athlone
Validation Engineer
Carlow
Senior Electronics Engineer
Dublin
Quality Engineer
Wexford
R&D Manager
Connaught
Process Development Engineer
Galway
CTO
Galway
Quality Manager
Galway
Senior R&D Engineer
Galway
Technical Life Cycle & Engineering M
Galway
Senior Regulatory Affairs Specialist
Dublin
Senior Quality Engineer
Leitrim
R&D Manager
Connaught
Quality Manager
Galway
Biomedical Engineer
Dublin
Operations Engineer
Galway
Quality Technician
Dublin
Quality and Regulatory Affairs Manager
Dublin
Marketing Manager
Galway
Principal R&D Engineer
Galway
Senior R&D Engineer
Galway
Manufacturing Technician
Galway
Quality Assurance Specialist (Hybrid)
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Quality Assurance Senior Specialist
Louth
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 Affairs Maanger


Reference:JCAO1807 Location: Galway
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs, Regulatory Affairs Consultant, Regulatory Affairs Director, Regulatory Affairs Manager

Regulatory Affairs Manager


Our client a fast-growing medical device company based in the West of Ireland, dedicated to transforming outcomes for patients are seeking a highly motivated Regulatory Affairs Manager to lead and oversee all regulatory compliance activities. This critical leadership role will define and execute regulatory strategies in support of both new product development and post-market activities.


Role/Responsibilities
  • Lead the regulatory strategy for new product introductions and support existing products through their full lifecycle.
  • Manage regulatory submissions (e.g. 510(k), CE Mark) and global product registrations.
  • Act as the primary contact for regulatory agencies, including authorities in the U.S. and Europe.
  • Monitor and interpret evolving regulatory requirements and apply them to ensure company compliance.
  • Partner with Quality Assurance to ensure post-market surveillance and vigilance activities meet applicable standards.
  • Review and approve promotional and advertising materials from a regulatory perspective.
  • Identify and allocate internal and external resources needed to maintain a robust regulatory function.
  • Provide strategic advice and cross-functional support on all regulatory matters.

Candidate Requirements
  • Bachelor’s degree in Engineering, Life Sciences, or a health-related field.
  • 10+ years of experience in the medical device industry, with a minimum of 3 years in a leadership or management role.
  • In-depth knowledge of US FDA and EU medical device regulations (including MDR).
  • Proven ability to handle complex regulatory submissions and interactions.
  • Excellent organizational, leadership, and communication skills.
  • A self-starter with a hands-on approach and the ability to thrive in a dynamic, entrepreneurial environment.
  • Previous experience in an SME or medtech startup is highly desirable.

For further information please contact James Cassidy [email protected] or call in confidence 086 0204322