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
Warehouse Operator
Meath
R&D Manager
Connaught
Senior Regulatory Affairs Specialist
Westmeath
Documentation Specialist
Louth
Senior R&D Engineer
Galway
Senior Quality Engineer
Galway
Senior Equipment Design Engineer
Dublin
Biomedical Engineer
Dublin
Senior Quality Engineer
Leitrim
Quality Engineer
Galway
Quality Engineer
Galway
CQV /CSV Quality Assurance Specialist (H
Dublin
Principal Engineer
Dublin
Senior Technician Quality Control
Carlow
Senior Principal R&D Engineer
Galway City
Quality Engineer - Supplier
Galway
Senior Electronic Engineer - Regulated M
Galway
Microbiology Manager
Dublin
QA Operations Specialist
Dublin
Staff Systems Engineer
Limerick
Quality Manager
Galway
Quality Engineer
Galway
Project Engineer - Senior
Cavan
Senior Process Engineer
Longford
Mechanical Engineer
Dublin
Director of R&D
Clare
Senior Quality Engineer
Dublin
Design Quality Engineer
Galway
R&D Director
Galway
Product Development Engineer
Dublin
Vigilance Assessor
Dublin
Continuous Improvement Coach
Limerick
R&D Director
Galway
Quality Technician
Galway
Design Assurance Engineer
Galway
Supply Chain Project Manager (hybrid)
Dublin
R&D Engineer
Dublin
R&D Engineer
Galway
Calibration Technician
Republic of Ireland
Sr Project Manager - Syringe Fill Engine
Dublin
Senior QC Microbiology
Dublin
Senior Quality Engineer
Dublin
Process Engineer
Leitrim
Senior Quality Assurance Specialist
Cork
Product Specialist (Critical Care &
Dublin
Graduate Occupational Hygiene Consultant
Kildare
Technical Transfer Specialist - Remote
Republic of Ireland
Product Development Technician II
Galway
Design Assurance Program Manager
Galway
R&D Manager
Galway
Equipment Engineer (Syringe Inspection S
Dublin
Senior Production Supervisor
Galway City
Principal R&D Engineer
Galway
Director of R&D
Limerick
QA Manager
Canada
R&D Engineer
Galway
Project Manager - New Product Introducti
Dublin
Injection Moulding Engineer
Athlone
Business Development Manager
Republic of Ireland
Senior Quality Systems Engineer
Galway
Senior Quality Engineer
Dublin
Project Manager (hybrid)
Dublin
R&D Engineer
Galway
Senior R&D Engineer
Galway
R&D Manager
Galway
Industrial Designer
Galway
Quality Manager
Dublin
Senior Manufacting Engineer
Republic of Ireland
Principal Device Engineer
Dublin
Warehouse Operator
Dublin
Senior Research Engineer
Galway
Project Engineer
Cork
CTO
Galway
Director Engineering & Supply Chain
Galway
Quality Control NPI Specialist
Carlow
Senior Quality Control Associate
Dublin South
Dental- Manager/ Senior Manager Business
Republic of Ireland
Senior Process Engineer - DP or DS
Dublin
Product Development Engineer II
Athlone
Dental- Manager/ Senior Manager Business
Republic of Ireland
Continuous Improvement Coach
Limerick
Senior Design Assurance Engineer
Galway
Project Engineer
Clare
Quality Manager
Dublin
Senior Quality Assurance Associate
Dublin
Commercial Attribute Science Snr Associa
Dublin
Technical Life Cycle & Engineering M
Galway
R&D Manager
Galway
Senior Equipment Design Engineer
Dublin
Purchasing & Planning Manager
Wexford
Engineering Shift Technician
Dublin
Principal Design Assurance Engineer
Galway
Quality Specialist
Dublin
Senior R&D Engineer
Galway
Product Specialist - Orthopaedic Divisio
Dublin
Quality Engineer
Athlone
CTO
Dublin
Senior Regulatory Affairs Specialist
Athlone
Commercial Solutions Manager (Medical De
Dublin
Environmental Health & Safety (EHS)
Longford
R&D Engineer
Dublin
Quality Specialist
Tipperary
Senior Equipment Engineer
Dublin
Project Manager
Kildare
Senior Regulatory Affairs Specialist
Clare
Senior Regulatory Affairs Specialist
Dublin
Senior Maintenance Technician
Kilkenny
Senior Research Scientist
Galway
EHS Specialist II
Limerick
Senior R&D Engineer
Galway
Senior Electrical Engineer
Galway
QA Engineer
Leitrim
Regulatory Affairs Specialist
Cork
Senior Human Factors Engineer
Galway
Tech Transfer Lead - Sterile Drug Produc
Dublin
Senior Clean Utilities Engineer
Dublin
Senior R&D Manager
Athlone
Process Chemist
Limerick
Senior Regulatory Affairs Specialist
Athlone
Senior Project Engineer - R&D
Galway
Program Manager (AVI Lines Operational R
Dublin
Quality Manager
Galway
Senior Associate Quality Control (Shift)
Dublin
Clinical Trial Manager
Republic of Ireland
Commercial Attribute Science Scientist
Dublin
Senior Quality Assurance Specialist (hyb
Dublin
R&D Technician II
Galway
Product Development Engineer II
Athlone
Principal R&D Engineer
Galway City
Senior Design Assurance Engineer
Galway
Quality Engineer - Supplier
Galway
Manufacturing Technician
Clare
Quality Assurance Team Lead
Cork
Senior Project Engineer
Cavan
Senior Research and Development Engineer
Galway
Software Design Assurance Engineer
Dublin
Manufacturing Technician
Clare
Senior Equipment Design Engineer
Dublin
Quality Manager
Galway
Quality Systems Manager
Dublin
Bioprocess Associate
Louth
Manufacturing Engineer
Galway
Senior Quality Engineer
Leitrim
Quality Engineer
Athlone
Senior Associate QC (QC Sample Managemen
Dublin
Director of Quality Engineering
Limerick
Senior Research Engineer
Galway
Senior R&D Manager
Athlone
R&D Engineer
Galway
Senior Process Development Engineer
Galway
Health & Safety Specialist
Louth
R&D Engineer
Clare
Project Manager
Kildare
R&D Manager
Connaught
Product Development Technician II
Galway
Regulatory Affairs Maanger
Galway
Validation Engineer
Republic of Ireland
Senior QA Specialist
Dublin
Quality Control Analyst (shift)
Carlow
Sr Principal R&D Engineer
Galway
Laboratory Systems Specialist
Meath
Biostatistician
Dublin
Senior Quality Engineer
Dublin
Strategic Automation Lead
Waterford
Quality Assurance Engineer
Longford
Senior Electronic Engineer
Dublin
Principal Software Engineer
Athlone
Design Assurance Engineer
Galway
R&D Engineer
Galway
Electrical Condition Monitoring Technici
Limerick
Quality Technician
Dublin
Senior QA Associate (shift)
Dublin
Health & Safety Specialist
Dublin
Senior R&D Engineer-New Product Deve
Westmeath
QC Bioanalytical Sciences - Senior Assoc
Dublin
Senior Regulatory Affairs Specialist
Athlone
R&D Senior Program Manager
Galway
R&D Manager
Athlone
Senior Electronics Engineer
Limerick
Quality Assurance Associate
Cork
Senior Design Engineer
Dublin
Manufacturing Technician
Clare
Principal R&D Engineer
Dublin
R&D Technician II
Galway
Senior Electronics Engineer
Dublin
Product Development Manager
Galway
Senior R&D Engineer
Galway
Injection Moulding Engineer
Leitrim
Senior R&D Engineer
Galway
Senior Product Development Engineer
Galway
Responsible Person (RP)
Republic of Ireland
R&D Engineer
Galway
Senior Reg Affairs Specialist - Post Mar
Galway
Warehouse Operator
Meath
R&D Manager
Dublin
R&D Manager
Athlone
Quality Engineer
Galway
Quality Assurance Specialist (Logistics)
Dublin
R&D Manager
Galway
Senior R&D Engineer
Clare
R&D Engineer
Galway
Senior Quality Engineer
Dublin
Senior R&D Engineer
Galway
Documentation Specialist
Louth
R&D Director
Galway
R&D Technician
Galway
Senior R&D Engineer
Dublin
Accreditation Manager
Republic of Ireland
Senior R&D Engineer
Galway
R&D Manager
Galway
Equipment Engineer (Formulation, Autocla
Dublin
Engineering Support Specialist
Louth
Technical Life Cycle & Engineering M
Galway
Manufacturing Technician
Clare
Principal Engineer
Dublin
Quality Technician
Dublin
Advanced Technologies R&D Manager
Clare
Principal Design Assurance Engineer
Galway
R&D Manager
Connaught
R&D Lifecycle Manager
Connaught
Validation Engineer
Carlow
Senior R&D Manager - Lifecycle Manag
Galway
R&D Manager
Connaught
Senior Operational Readiness Associate
Dublin
Senior Design Assurance Engineer
Galway
Supplier Quality Engineer
Galway
Senior Operations Engineer
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

Director of Regulatory Affairs


Reference:JCAO0203 Location: Galway
Qualification:DegreeExperience:10+ Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Regulatory Affairs Director, Regulatory Affairs Manager

Director of Regulatory Affairs 📍 Galway, Ireland (Hybrid)
Lead Regulatory Strategy in a High-Growth MedTech Environment An innovative, growth-stage medical device company based in Galway is seeking an experienced Director of Regulatory Affairs to lead global regulatory strategy and compliance activities.
This is a senior leadership opportunity within a dynamic SME environment, offering the chance to shape regulatory direction while partnering closely with executive leadership and cross-functional teams.

The Opportunity Reporting to the executive team, you will take full ownership of regulatory compliance, design assurance, and risk management activities across the organisation.
This role requires strategic oversight combined with a hands-on approach, suited to an experienced regulatory leader who thrives in fast-paced, innovation-driven environments.
Key Responsibilities
  • Act as Person Responsible for Regulatory Compliance (PRRC) under EU MDR (2017/745).
  • Define and execute global regulatory strategy for new product development and lifecycle management.
  • Lead all regulatory submissions including FDA 510(k) and CE Mark applications.
  • Manage regulatory authority interactions (FDA, Notified Body, Competent Authorities).
  • Oversee design assurance and risk management processes.
  • Ensure compliance with post-market surveillance and vigilance requirements (EU & US).
  • Lead regulatory review of promotional and advertising materials.
  • Direct regulatory strategy related to field actions or recalls if required.
  • Build, mentor, and develop regulatory and design assurance capability.
  • Provide strategic regulatory guidance at executive level.
About You You are a seasoned regulatory professional with strong leadership capability and a collaborative mindset. You bring both technical depth and the ability to operate strategically at senior level.
Experience & Qualifications
  • Degree in Engineering, Science, or health-related discipline.
  • 15+ years’ experience within the medical device industry.
  • Minimum 7 years in a senior leadership role.
  • Deep understanding of EU MDR and US FDA regulatory pathways.
  • Proven experience leading 510(k) and CE Mark submissions.
  • Strong background in design control and risk management.
  • Experience working within an SME or high-growth MedTech environment is highly desirable.
Personal Attributes
  • Strategic thinker with a pragmatic, hands-on approach.
  • Highly organised with strong prioritisation capability.
  • Comfortable managing complexity in a growing organisation.
  • Strong interpersonal and communication skills.
  • Proven ability to lead, coach, and develop teams.
Why Apply?
  • Senior leadership role with significant influence.
  • Opportunity to shape regulatory strategy within an innovative organisation.
  • Collaborative and inclusive working environment.
  • Competitive package aligned with experience.
For further information please contact James Cassidy [email protected] or call in confidence 086 0204322