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
Staff Systems Engineer
Limerick
R&D Director
Galway
Principal Reliability Engineer
Galway
Supplier Quality Engineer
Galway
Senior R&D Manager
Athlone
Engineering Shift Technician
Dublin
Project Engineer - Senior
Cavan
Manufacturing Specialist - Investigation
Dublin
Senior R&D Engineer
Galway
Senior Process Development Engineer
Galway
Purchasing & Planning Manager
Wexford
Sterilisation Manager
Tipperary
Graduate Occupational Hygiene Consultant
Kildare
Senior QC Associate
Dublin
Quality Manager
Galway
Industrial Designer
Galway
Senior Equipment Design Engineer
Dublin
Principal Design and Development Enginee
Galway
Equipment Engineer (Syringe filling)
Dublin
Continuous Improvement Coach
Limerick
Senior R&D Engineer
Galway
Senior Principal Design and Development
Galway
R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Dublin
Senior Project Engineer
Cavan
Warehouse Operator
Meath
Manufacturing Technician
Clare
Strategic Automation Lead
Waterford
Injection Moulding Engineer
Leitrim
Principal Process Equipment Engineer
Dublin South
Senior Electronic Engineer
Dublin
R&D Manager
Connaught
Project Engineer
Roscommon
Senior Project Engineer
Cavan
R&D Director
Galway
Senior Quality Engineer
Galway
Senior Quality Control Associate
Dublin South
Principal R&D Engineer
Galway
Senior R&D Engineer
Galway
Director of Regulatory Affairs
Galway
Continuous Improvement Coach
Limerick
R&D Manager
Galway
Engineering Business Manager
Dublin
Senior Design Engineer
Dublin
R&D Senior Program Manager
Galway
Senior QC Systems Validation Associate
Dublin
Senior Operations Engineer
Galway
R&D Manager
Athlone
Senior R&D Engineer
Galway
Senior Reg Affairs Specialist - Post Mar
Galway
CTO
Dublin
Quality Engineer
Galway
QA Manager
Canada
Quality Assurance Senior Specialist
Louth
Principal Engineer
Dublin
Senior Process Engineer - DP or DS
Dublin
Supplier Quality Engineer
Galway
Principal R&D Engineer
Galway
Senior Process Engineer
Dublin
Commercial Solutions Manager (Medical De
Dublin
Product Development Engineer
Dublin
R&D Manager
Galway
Senior Manufacturing Engineer
Galway
Senior Maintenance Technician
Kilkenny
Quality Engineer
Wexford
Operations Engineer
Galway
Principal Software Engineer
Athlone
Senior R&D Engineer
Galway
Purchasing & Planning Manager
Wexford
Documentation Specialist
Louth
Senior Equipment Design Engineer
Dublin
Strategy Associate Director / Director -
Dublin
Senior Process Engineer
Longford
Senior Manufacting Engineer
Republic of Ireland
Senior Operations Engineer
Galway
R&D Manager
Galway
Senior Regulatory Affairs Specialist
Athlone
QC Micro Analyst (4 cycle shift)
Cork
Design Assurance Engineer
Galway
Senior Quality Assurance Specialist
Cork
Process Chemist
Limerick
Senior Associate QC (QC Sample Managemen
Dublin
Senior R&D Engineer
Galway
Commercial Attribute Science Scientist
Dublin
Project Manager (Pharma)
Dublin
Principal R&D Engineer
Dublin
Senior Quality Engineer
Galway
R&D Engineer
Galway
Principal R&D Engineer
Galway City
Project Manager
Galway
Senior Product Development Engineer
Galway
QA Engineer
Leitrim
R&D Manager
Connaught
Engineering Support Specialist
Louth
Quality Specialist
Tipperary
Quality Technician
Dublin
Senior R&D Engineer
Dublin
Project Engineer
Clare
Calibration Technician
Republic of Ireland
Senior Design Assurance Engineer
Galway
Equipment Engineer (Formulation, Autocla
Dublin
Documentation Specialist
Louth
Quality Specialist
Clare
Senior Regulatory Affairs Manager
Galway
Quality Assurance Engineer
Longford
Senior R&D Engineer-New Product Deve
Westmeath
Project Manager
Kildare
Product Specialist (Critical Care &
Dublin
Clinical Trial Manager
Republic of Ireland
R&D Director
Galway
Injection Moulding Engineer
Athlone
Director of Quality Engineering
Limerick
Engineering Support Specialist
Louth
Quality Assurance Associate
Cork
Senior Design Assurance Engineer
Galway
Senior Operations Engineer
Galway
Regulatory Affairs Specialist
Cork
R&D Engineer
Dublin
Advanced Technologies R&D Manager
Clare
Senior Regulatory Affairs Specialist
Athlone
Technical Life Cycle & Engineering M
Galway
QA Operations Specialist
Dublin
Senior Regulatroy Affairs Specialsit
Galway
Senior Microbiologist
Dublin
Change Control Specialist
Tipperary
Senior Clean Utilities Engineer
Dublin
Senior Electronics Engineer
Dublin
Senior Quality Engineer
Dublin
Senior Principal R&D Engineer
Galway City
R&D Engineer
Galway
Quality Assurance Specialist (hybrid)
Dublin
R&D Technician
Galway
R&D Engineer
Dublin
Software Design Assurance Engineer
Dublin
R&D Engineer
Galway
Principal Quality Engineer
Galway
R&D Manager
Athlone
Process Development Engineer
Galway
CQV Engineer
Dublin
Principal Engineer
Dublin
Quality Engineer
Athlone
Quality Specialist
Clare
Maintenance & Reliability Technician
Limerick
Quality Engineer - Supplier
Galway
Supply Chain Project Manager (hybrid)
Dublin
R&D Engineer
Galway
Principal Design Assurance Engineer
Galway
CTO
Galway
Senior Quality Systems Engineer
Galway
Quality Manager
Galway
Mechanical Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Senior Manufacturing Engineer
Galway City
R&D Manager
Connaught
Senior Regulatory Affairs
Galway
Business Development Manager (Hospitals)
Cork
Senior Associate Quality Control
Dublin
Continuous Improvement Coach
Limerick
Senior R&D Engineer
Galway
Director Engineering & Supply Chain
Galway
Principal Engineer
Dublin
Business Development Manager (Hospitals)
Cork
Senior Design Assurance Engineer
Athlone
Quality Engineer
Galway
Business Development Manager
Republic of Ireland
Quality Manager
Dublin
Senior Design Engineer
Dublin
Principal R&D Engineer
Galway
Quality Specialist
Clare
Senior R&D Engineer
Galway
Technical Life Cycle & Engineering M
Galway
Sr Project Manager - Syringe Fill Engine
Dublin
R&D Manager
Connaught
Electronic Engineering
Dublin
Director of R&D
Limerick
Senior Quality Engineer
Leitrim
Health & Safety Specialist
Dublin
Project Manager
Kildare
Senior Quality Engineer
Dublin
Quality Assurance Specialist (Logistics)
Dublin
Senior Research and Development Engineer
Galway
Senior R&D Engineer
Clare
Quality Specialist
Dublin
Process Engineer
Galway
Accreditation Manager
Republic of Ireland
Production Operator
Meath
Advanced Technologies Manager
Galway
Senior Quality Engineer
Dublin
Quality Technician
Dublin
Senior Quality Engineer
Dublin
R&D Engineer
Galway
Quality Control NPI Specialist
Carlow
Senior Regulatory Specialist
Cork
R&D Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
R&D Manager
Galway
R&D Director
Galway
Senior Maintenance Technician
Kilkenny
Responsible Person (RP)
Republic of Ireland
Senior Electronics Engineer
Limerick
Validation Engineer
Carlow
Project Manager (hybrid)
Dublin
Biomedical Engineer
Dublin
Senior Quality Assurance Technical Suppo
Dublin
R&D Manager
Dublin
Senior Quality Engineer
Leitrim
Senior R&D Engineer
Clare
R&D Manager
Galway
Senior R&D Engineer
Galway
Sr Electrical Engineer
Galway
Senior Design Assurance Engineer
Galway
R&D Engineer
Clare
Director of Regulatory Affairs
Galway
Quality Systems Manager
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 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