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
Senior Quality Control Associate
Dublin South
Senior Design Assurance Engineer
Galway
Principal R&D Engineer
Galway
Operations Manager
Galway
Quality Assurance Associate
Cork
Senior R&D Engineer
Dublin
Principal Reliability Engineer
Galway
Software Design Assurance Engineer
Dublin
R&D Director
Galway
Senior Manufacting Engineer
Republic of Ireland
R&D Engineer
Galway
Quality Specialist
Tipperary
QC Microbiology Technician
Kildare
Senior R&D Manager - Lifecycle Manag
Galway
Senior Maintenance Technician
Kilkenny
Senior Product Development Engineer
Galway
Quality Manager
Galway
Senior QC Microbiology
Dublin
Senior Regulatory Affairs
Galway
Senior Supply Chain Manager - Supplier E
Dublin
Senior R&D Engineer
Clare
Sales Specialist (Life Sciences)
Dublin
Project Manager
Kildare
Senior Quality Engineer
Galway
Senior Process Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Proposal Manager
Dublin
Senior Clinical Engagement Project Manag
Dublin
Senior Production Manager
Cork
Senior Regulatory Specialist
Cork
Principal Software Engineer
Athlone
Manufacturing Technician
Clare
R&D Director
Galway
Senior Research and Development Engineer
Galway
Senior Regulatory Specialist
Cork
R&D Engineer
Galway
Process Engineer - Sterile Drug Product
Waterford
Biomedical Engineer
Dublin
Reg Affairs Specialist
Connaught
Manufacturing Technician
Clare
Senior Operations Engineer
Galway
Quality and Regulatory Affairs Manager
Dublin
Senior Reg Affairs Specialist - Post Mar
Galway
Head of Sector (Healthcare)
Dublin
Senior Equipment Engineer
Dublin
Senior Research and Development Engineer
Galway
Senior Design Engineer
Dublin
Senior Quality Engineer
Dublin
QC Specialist
Clare
R&D Engineer
Galway
R&D Manager
Connaught
Quality Technician
Galway
Environmental Health & Safety (EHS)
Longford
QA Manager
Canada
Principal Design Assurance Engineer
Galway
Sustainability Lead (Pharmaceutical)
Dublin
Senior Technology Transfer Specialist
Dublin
Senior Quality Engineer
Dublin
Senior Quality Assurance Specialist
Cork
Director of R&D
Limerick
Quality Manager
Dublin
R&D Manager
Galway
Lead Mechanical Design Engineer
Limerick
LIMS Specialist
Tipperary
Microbiology Manager
Dublin
Design Quality Engineer
Galway
Continuous Improvement Specialist
Dublin
Quality Assurance Specialist (shift)
Carlow
Director of Quality Engineering
Limerick
Quality Engineer
Galway
QC Microbiology Analyst
Dublin
R&D Manager
Dublin
Senior Design Assurance Engineer
Galway
Senior Process Development Engineer
Galway
Senior Product Development Engineer
Galway
Principal R&D Engineer
Dublin
Territory Manager (Endoscopy)
Dublin
R&D Manager
Galway
Regulatory Affairs Specialist
Cork
Quality Assurance Specialist (shift)
Carlow
Quality Engineer
Athlone
Quality Engineer
Wexford
Shift Technician (Injection Moulding)
Kildare
Senior QC Microbiology
Dublin
Senior Quality Assurance Associate
Dublin
Senior R&D Engineer
Galway
Manufacturing Specialist - Investigation
Dublin
Principal R&D Engineer
Galway
R&D Director
Galway
Quality Manager - NPI
Dublin
Design Assurance Engineer
Galway
Business Development Manager
Republic of Ireland
R&D Lifecycle Manager
Connaught
Quality Assurance Specialist/Manager
Dublin
Laboratory Systems Specialist
Meath
Quality Assurance Senior Specialist
Louth
Senior Quality Engineer
Dublin
Documentation Specialist
Louth
Supply Chain Specialist - New Material I
Meath
Product Development Engineer
Dublin
Senior Product Development Engineer
Galway
Senior R&D Manager
Athlone
R&D Engineer
Galway
Product Specialist (Critical Care &
Dublin
Injection Moulding Engineer
Athlone
Director of R&D
Galway
Tech Transfer Lead
Dublin
Engineering Business Manager
Dublin
Senior QC Specialist
Dublin
Senior Associate Quality Control
Dublin
Product Development Manager
Galway
Quality Manager
Galway
R&D Manager
Galway
Quality Manager
Galway
R&D Engineer
Clare
R&D Manager
Athlone
EHSS Specialist
Athlone
Senior Electronic Engineer
Dublin
Senior Maintenance Technician
Kilkenny
Principal R&D Engineer
Dublin
Supply Chain Project Manager (hybrid)
Dublin
Staff R&D Engineer
Limerick
Senior Quality Assurance Associate
Dublin
Process Engineer
Galway
R&D Manager
Connaught
Senior R&D Manager - Lifecycle Manag
Galway
NPI Engineer - Hybrid
Dublin
Quality Assurance Specialist (hybrid)
Dublin
Senior Regulatory Affairs Specialist
Clare
Senior Quality Engineer
Dublin
Quality Engineer - Supplier
Galway
Quality Engineer
Galway
Principal Engineer
Dublin
Senior Manufacturing Engineer
Cork
Project Manager (hybrid)
Dublin
R&D Manager
Galway
Product Specialist (Critical Care &
Dublin
Senior QC Associate (Bioassay)
Dublin
Documentation Specialist
Louth
Quality Manager
Galway
Application Software Engineer
Galway
Design Assurance Engineer
Galway
Operations Lead
Dublin
Senior Director of Manufacturing and Sup
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Quality Manager
Dublin
Project Engineer
Roscommon
Quality Engineer
Galway
Senior Design Engineer
Dublin
Senior Regulatory Affairs Specialist
Dublin
(Senior) Manufacturing Engineers - Globa
Limerick
Operations Engineer
Galway
Sales Manager (Healthcare)
Dublin
Senior Project Manager
Meath
R&D Engineer
Dublin
R&D Engineer
Galway
Senior R&D Engineer
Galway
Senior QC Analyst
Republic of Ireland
R&D Engineer
Dublin
Biomedical Engineer
Dublin
Injection Moulding Engineer
Leitrim
Senior QC Associate - Equipment & I
Dublin
Senior Equipment Design Engineer
Dublin
Supplier Quality Engineer
Galway
Bid Response Strategy Manager
Dublin
Sales/Customer Service Administrator
Clonmel
Product Development Engineer
Galway
Senior Clinical Data Analyst
Dublin
Principal Device Engineer
Dublin
R&D Manager
Galway
Principal Quality Engineer
Galway
Senior Equipment Design Engineer
Dublin
Business Development Manager (Pharmacy O
Dublin
Senior Quality Engineer
Galway
Equipment Engineer Intermediate
Dublin
Process Chemist
Limerick
Manufacturing Technician
Clare
R&D Engineer
Galway
R&D Manager
Connaught
Quality Assurance Specialist
Waterford
Product Development Engineer
Galway
Senior Human Factors Engineer
Galway
R&D Technician
Galway
Principal R&D Engineer
Galway
Principal R&D Engineer
Galway
Tech Transfer Lead - Sterile Drug Produc
Dublin
Clinical Trial Protocol Specialist
Galway
Senior Mechanical Engineer
Dublin
Product Development Engineer II
Athlone
QA Engineer
Leitrim
R&D Technician II
Galway
Senior Equipment Design Engineer
Dublin
Senior Quality Engineer
Galway
Documentation Specialist
Louth
R&D Manager
Athlone
CTO
Dublin
Senior Project Engineer
Cork
Senior Engineering Manager
Limerick
Quality Assurance Team Lead
Cork
R&D Manager
Connaught
Sr Principal R&D Engineer
Galway
Responsible Person (RP)
Republic of Ireland
R&D Engineer
Galway
Senior Principal Design and Development
Galway
Project Manager - New Product Introducti
Dublin
Environmental Health & Safety (EHS)
Longford
Senior Operations Engineer
Galway
Senior Equipment Design Engineer
Dublin
Senior Operational Readiness Associate
Dublin
Process Scientist MSAT
Louth
Director Engineering & Supply Chain
Galway
Senior Quality Assurance Technical Suppo
Dublin
R&D Director
Galway
Quality Assurance Specialist (Hybrid)
Dublin
Senior Regulatory Affairs Specialist
Athlone
R&D Engineer
Galway
Senior Equipment Engineer
Dublin
R&D Engineer
Galway
Calibration Technician
Republic of Ireland
Senior Commissioning & Qualification
Roscommon
CTO
Galway
Senior Clinical Data Analyst
Dublin
R&D Engineer
Galway
Senior R&D Engineer
Galway
Quality Control (QC) Technician
Kildare
Product Development Engineer II
Athlone
Senior Project Engineer
Cavan
Senior Process Engineer
Longford
Senior Manufacturing Engineer
Galway
Project Manager - R&D
Galway
Clinical Trial Protocol Specialist
Galway
Lead MSAT Validation Consultant
Republic of Ireland
Senior Operational Readiness Associate
Dublin
Project Manager
Kildare
Senior Quality Engineer
Dublin
Senior Maintenance Technician
Kilkenny
Advanced Technologies R&D Manager
Clare
Quality System & Regulatory Affairs
Galway
Quality Engineer
Athlone
Senior Product Development Engineer
Galway
Industrial Designer
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