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
Quality Manager
Dublin
Project Manager
Kildare
R&D Manager
Connaught
Electronic Engineer
Dublin
Senior Research & Development Engine
Limerick
Senior Quality Engineer
Leitrim
Senior Quality Engineer
Dublin
Principal Instrumentation & Calibrat
Limerick
Injection Moulding Engineer
Athlone
Senior Design Assurance Engineer
Athlone
Quality Engineer
Galway
Manufacturing Technician
Clare
R&D Director
Galway
Electrical Technician
Limerick
Senior R&D Manager - Lifecycle Manag
Galway
Senior R&D Engineer
Galway
Manufacturing Technician
Clare
Quality Manager - Medical Devices
Limerick City
R&D Engineer
Galway
Senior Operations Engineer
Galway
Business Development Manager (Pharma &am
Republic of Ireland
Strategic Automation Lead
Waterford
Microbiology Manager
Dublin
Senior R&D Engineer
Galway
Territory Manager (Woundcare) - Dublin -
Dublin
Injection Moulding Engineer
Athlone
Senior Regulatroy Affairs Specialsit
Galway
Advanced Technologies Manager
Galway
R&D Manager
Galway
Quality Manager
Galway
R&D Director
Galway
Regulatory Affairs Associate
Cork
Senior Equipment Design Engineer
Dublin
Senior Project Engineer
Cavan
QC Bioanalytical Sciences - Senior Assoc
Dublin
Continuous Improvement Coach
Limerick
Principal Design and Development Enginee
Galway
Principal Engineer
Dublin
Documentation Specialist
Louth
Product Development Engineer
Dublin
Project Manager Design Assurance
Galway
R&D Technician
Galway
Calibration Technician
Republic of Ireland
Quality Engineer
Athlone
QA Engineer
Leitrim
Process Development Engineer
Galway
Validation Engineer
Athlone
R&D Engineer
Galway
R&D Director
Galway
Senior Quality Engineer
Leitrim
R&D Manager
Connaught
Quality Manager - NPI
Dublin
Quality Specialist
Tipperary
Product Development Engineer II
Athlone
Quality Engineer
Athlone
Senior Electronic Engineer
Dublin
QA Manager
Canada
Product Development Engineer
Galway
Senior Design Assurance Engineer
Galway
Senior Design Assurance Engineer
Galway
Engineering Shift Technician
Dublin
Senior Maintenance Technician
Roscommon
Electronic Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Principal R&D Engineer
Galway City
R&D Program Manager
Dublin
Injection Molding Engineer
North Leinster
Process Chemist
Limerick
Design Assurance Program Manager
Galway
Senior R&D Engineer
Dublin
Process Engineer
Roscommon
Mechanical Technician
Carlow
Senior R&D Engineer
Dublin
R&D Engineer
Dublin
Project Engineer
Cork
R&D Manager
Galway
Project Manager - New Product Introducti
Dublin
Senior Maintenance Technician
Kilkenny
Product Development Technician II
Galway
Senior R&D Engineer
Galway
Senior Manufacturing Engineer
Galway
Regulatory Specialist
Galway
Senior Regulatory Affairs Specialist
Athlone
Electronic Engineer
Dublin
R&D Engineer
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Senior Quality Engineer
Galway
Senior / Lead Electrical Engineer
Limerick
Design Assurance Program Manager
Galway
Quality Engineer
Galway
Senior Clinical Affairs Specialist (Remo
Republic of Ireland
Senior Regulatory Affairs Specialist
Dublin
Project Manager - R&D
Galway
Product Development Engineer
Dublin
Principal Software Engineer
Athlone
Principal R&D Engineer
Galway
Project Manager
Kildare
Senior Product Development Engineer
Galway
Project Manager - R&D
Galway
R&D Engineer
Galway
Senior Project Engineer
Cavan
Operations Engineer
Galway
Quality Engineer
Galway
Senior Electronics Engineer
Limerick
CTO
Galway
Senior Quality Systems Engineer
Galway
R&D Engineer
Galway
Process Engineer
Roscommon
Senior Associate Quality Control (Shift)
Dublin
Purchasing & Planning Manager
Wexford
R&D Manager
Dublin
R&D Manager
Connaught
Design Assurance Engineer
Galway
R&D Manager
Athlone
R&D Manager
Connaught
Quality Assurance Specialist (Logistics)
Dublin
Growth Manager (Healthcare)
Dublin
Engineering Support Specialist
Louth
R&D Manager
Galway
Electronic Engineer
Dublin
Responsible Person (RP)
Republic of Ireland
R&D Manager
Galway
Process Engineer
Roscommon
CTO
Dublin
Senior R&D Manager
Athlone
Senior Quality Engineer
Dublin
Mechanical Engineer
Dublin
Principal Reliability Engineer
Galway
R&D Engineer
Galway
Product Development Engineer
Dublin
R&D Scientist (Microbiology)
Wexford
Manufacturing Technician
Clare
Senior R&D Engineer
Galway
R&D Manager
Athlone
Sales/Customer Service Administrator
Clonmel
Senior R&D Engineer
Galway
(Senior) Manufacturing Engineers - Globa
Limerick
Project Manager
Galway
Product Development Engineer
Dublin
Process Engineer
Dublin
Engineering Support Specialist
Louth
Electronic Engineer
Dublin
Learning Systems Lead
Limerick
Senior R&D Engineer-New Product Deve
Westmeath
R&D Engineer
Galway
Quality Specialist
Clare
Senior Mechanical Engineer
Dublin
Senior R&D Engineer
Galway
EHS Officer
Dublin
Senior Quality Engineer
Leitrim
Technical Life Cycle & Engineering M
Galway
Maintenance & Reliability Technician
Limerick
Quality Engineer
Galway
Quality Engineer
Galway
R&D Engineer
Galway
Senior R&D Engineer
Galway
Injection Moulding Engineer
Athlone
R&D Engineer
Clare
Reg Affairs Specialist
Connaught
Senior Regulatory Affairs Specialist
Athlone
Senior R&D Engineer
Galway
R&D Engineer
Galway
Senior Quality Assurance Specialist
Cork
Production Manager
Dublin
R&D Engineer
Galway
Project Manager - R&D
Galway
Regulatory Affairs Specialist
Cork
Senior R&D Engineer
Galway
Quality Assurance Associate
Cork
Production Operator
Meath
Manufacturing Technician
Clare
Senior Quality Engineer
Dublin
Electronic Engineer
Dublin
Validation & Verification Engineer
Dublin
Quality Engineer
Galway
Injection Moulding Engineer
Leitrim
Product Development Engineer
Dublin
Senior Quality Engineer
Leitrim
Principal R&D Engineer
Dublin
Senior Operations Engineer
Galway
R&D Director
Galway
Senior R&D Engineer
Galway
Senior Regulatory Specialist
Cork
R&D Manager
Galway
Senior Quality Engineer
Dublin
Senior Research and Development Engineer
Galway
Injection Molding Engineer
North Leinster
Senior Quality Engineer
Dublin
R&D Engineer
Galway
Documentation Specialist
Louth
Principal Engineer
Dublin
Customer Services Manager (Pharmaceutica
Dublin
Senior Regulatory Affairs Specialist
Westmeath
Principal R&D Engineer
Galway
Senior Manufacting Engineer
Republic of Ireland
Manufacturing Technician
Galway
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