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 QA Associate (shift)
Dublin
Senior Regulatory Affairs Specialist
Athlone
Production Operator
Meath
Senior Quality Assurance Specialist
Cork
Product Development Engineer II
Athlone
Senior Quality Control Associate
Dublin South
Instrumentation Engineer
Meath
Quality Manager
Galway
Quality Manager
Galway
Senior Equipment Design Engineer
Dublin
Process Development - Senior Project Man
Dublin
Quality Manager
Galway
Quality Assurance Specialist
Carlow
Injection Moulding Engineer
Athlone
Quality Manager
Galway
Principal R&D Engineer
Dublin
Senior Quality Engineer
Galway
Lead MSAT Validation Consultant
Republic of Ireland
Principal R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Westmeath
Tech Transfer Lead
Dublin
Lead Mechanical Design Engineer
Limerick
R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Dublin
Design Assurance Program Manager
Galway
LIMS Specialist
Tipperary
Senior QC Specialist
Dublin
R&D Director
Galway
Quality Assurance Team Lead
Cork
Senior Human Factors Engineer
Galway
R&D Manager
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Design Assurance Engineer
Galway
CTO
Dublin
Quality Engineer
Athlone
Laboratory Systems Specialist
Meath
Supply Chain Project Manager (hybrid)
Dublin
Senior Maintenance Technician
Kilkenny
R&D Engineer
Galway
Sr Project Manager - Syringe Fill Engine
Dublin
Senior R&D Engineer
Galway
R&D Manager
Connaught
Senior Regulatory Affairs Specialist
Athlone
Senior Quality Engineer
Dublin
Senior Quality Engineer
Dublin
Senior Process Engineer - DP or DS
Dublin
Product Development Engineer
Galway
Process Engineer
Galway
Senior Equipment Design Engineer
Dublin
Principal Process Equipment Engineer
Dublin South
Quality Manager
Galway
Senior QC Microbiology
Dublin
Senior Operational Readiness Associate
Dublin
Principal Device Engineer
Dublin
Design Assurance Engineer
Galway
Senior Equipment Engineer
Dublin
Quality Engineer - Supplier
Galway
Clinical Trial Protocol Specialist
Galway
Senior Quality Assurance Associate
Dublin
Product Development Manager
Galway
Senior R&D Engineer
Clare
Senior Quality Assurance Technical Suppo
Dublin
Senior Clinical Data Analyst
Dublin
Senior R&D Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Senior R&D Engineer
Galway
Senior Supply Chain Project Manager
Dublin
Senior Electronic Engineer
Dublin
R&D Technician II
Galway
Senior R&D Engineer
Dublin
Principal R&D Engineer
Dublin
R&D Engineer
Dublin
Senior R&D Engineer
Galway
Quality Specialist
Tipperary
Construction Manager - Pharma/Biotech
Dublin
Industrial Engineer Capacity Planning
Dublin
R&D Director
Galway
R&D Manager
Galway
Sr Electrical Engineer
Galway
Technical Transfer Specialist - Remote
Republic of Ireland
Production Manager
Dublin
Principal R&D Engineer
Galway
Senior Design Engineer
Dublin
R&D Engineer
Galway
Senior Design Assurance Engineer
Galway
Senior Electronics Engineer
Limerick
Technical Life Cycle & Engineering M
Galway
Senior Technical Writer
Dublin
Product Development Engineer
Galway
QA Engineer
Leitrim
Product Development Engineer II
Athlone
R&D Engineer
Clare
Quality Assurance Specialist
Carlow
Manufacturing Technician
Clare
Senior Maintenance Technician
Kilkenny
R&D Manager
Galway
Senior R&D Engineer
Dublin
Quality Specialist
Clare
R&D Manager
Connaught
Environmental Health & Safety (EHS)
Longford
R&D Engineer
Galway
R&D Engineer
Dublin
Quality Assurance Specialist (hybrid)
Dublin
Manufacturing Engineer
Galway
Regulatory Affairs Maanger
Galway
Senior Associate Quality Control
Dublin
R&D Engineer
Galway
Project Engineer
Cork
Design Assurance Manager
Galway
R&D Engineer
Galway
Senior R&D Engineer II
Galway
R&D Engineer
Galway
Director of Quality Engineering
Limerick
Manufacturing Specialist - Investigation
Dublin
CTO
Galway
Microbiology Manager
Dublin
Quality Manager
Galway
Quality Technician
Galway
Project Engineer
Clare
Project Manager
Kildare
Documentation Specialist
Louth
Equipment Engineer (Syringe filling)
Dublin
Senior Manufacturing Engineer
Galway
Quality Engineer - Supplier
Galway
Senior Operations Engineer
Galway
Supplier Quality Engineer
Galway
Senior Regulatory Affairs
Galway
R&D Manager
Athlone
Embedded Software Engineer
Dublin
Project Manager
Kildare
Senior Principal Design and Development
Galway
Director of R&D
Limerick
EHS Specialist II
Limerick
Calibration Technician
Republic of Ireland
Quality Assurance Specialist (Logistics)
Dublin
R&D Manager
Dublin
Inside Sales Support & Sourcing Spec
Dublin
R&D Manager
Connaught
R&D Director
Galway
Documentation Specialist
Louth
Senior Process Development Engineer
Galway
Manufacturing Technician
Clare
Project Manager - R&D
Galway
Senior Quality Engineer
Leitrim
Quality Manager - NPI
Dublin
Process Scientist MSAT
Louth
Senior R&D Manager - Lifecycle Manag
Galway
Environmental Health & Safety (EHS)
Longford
Health & Safety Specialist
Dublin
Senior Operations Engineer
Galway
Product Development Engineer
Galway
Quality Engineer
Wexford
Senior Technology Transfer Specialist
Dublin
Director Engineering & Supply Chain
Galway
Senior Design Assurance Engineer
Galway
Product Specialist (Critical Care &
Dublin
Senior Clinical Data Analyst
Dublin
Quality Assurance Specialist
Waterford
Senior Process Engineer
Longford
Senior Design Assurance Engineer
Galway
Principal R&D Engineer
Galway
Senior Regulatory Affairs Manager
Galway
R&D Manager
Athlone
Quality Technician
Galway
US based EAP Program Manager
Outside EU
Electronic Engineering
Dublin
Mechanical Technician
Carlow
Senior Quality Engineer
Galway
R&D Manager
Connaught
QC Specialist
Clare
R&D Program Manager
Dublin
Senior Quality Engineer
Dublin
Business Resilience Specialist
Dublin
Senior Quality Systems Engineer
Galway
Senior Manufacturing Engineer
Galway City
Supply Chain Specialist - New Material I
Meath
Senior Regulatory Affairs Specialist
Athlone
R&D Technician II
Galway
R&D Engineer
Galway
Bioinformatician
Dublin
A.I Specialist
Clare
Senior R&D Engineer
Galway
Marketing Manager
Galway
Sales Manager (Healthcare)
Dublin
Senior Project Engineer
Cavan
Sales Specialist (Life Sciences)
Dublin
Senior R&D Engineer
Galway
Senior Process Engineer - Packaging
Dublin
QA Deviations Specialist
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Application Software Engineer
Galway
Senior Quality Engineer
Galway
R&D Senior Program Manager
Galway
R&D Manager
Galway
R&D Lifecycle Manager
Connaught
Clinical Sales Specialist (Histology)
Dublin
Senior Commissioning & Qualification
Roscommon
Project Engineer
Roscommon
Design Quality Engineer
Galway
Senior Manufacting Engineer
Republic of Ireland
Product Specialist (Critical Care &
Dublin
R&D Engineer
Galway
Regulatory Affairs Manager- Remote
Republic of Ireland
Senior NPI Engineer - Hybrid
Dublin
Principal Engineer
Dublin
Senior Quality Engineer
Dublin
Quality Technician
Dublin
Quality Technician
Dublin
A.I Specialist
Clare
Senior R&D Engineer
Galway
Senior Clinical Data Analyst
Dublin
Process Chemist
Limerick
Senior Design Engineer
Dublin
R&D Engineer
Galway
Learning Systems Lead
Limerick
Responsible Person (RP)
Republic of Ireland
Senior R&D Engineer-New Product Deve
Westmeath
Quality Assurance Team Lead
Cork
Reg Affairs Specialist
Connaught
Validation Engineer
Athlone
CAPEX API Project Manager
Tipperary
Senior Microbiologist
Dublin
QA Manager
Canada
Principal Software Engineer
Athlone
Senior Project Manager
Meath
Business Development Manager
Republic of Ireland
Senior Electronic Engineer
Dublin
R&D Manager
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

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