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
Process Engineer
Leitrim
Principal Engineer
Dublin
Project Engineer
Cork
Sr Electrical Engineer
Galway
Business Development Manager (Hospitals)
Cork
Senior R&D Engineer
Dublin
R&D Manager
Connaught
Industrial Designer
Galway
Dental- Manager/ Senior Manager Business
Republic of Ireland
Senior Associate Quality Control
Dublin
Senior R&D Engineer
Galway
R&D Manager
Athlone
Senior Quality Engineer
Dublin
Clinical Safety Specialist
Dublin
Quality Technician
Dublin
Senior Process Engineer
Longford
Continuous Improvement Coach
Limerick
Quality Assurance Specialist (hybrid)
Dublin
Product Development Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Senior Electrical Engineer
Galway
Responsible Person (RP)
Republic of Ireland
Engineering Shift Technician
Dublin
R&D Technician II
Galway
Equipment Engineer (Syringe Inspection S
Dublin
Senior NPI Engineer - Hybrid
Dublin
Senior Quality Engineer
Leitrim
Manufacturing Technician
Clare
Senior Project Engineer
Cavan
Principal Design and Development Enginee
Galway
Senior Regulatory Affairs
Galway
Senior Quality Engineer
Leitrim
R&D Manager
Dublin
R&D Manager
Connaught
R&D Engineer
Galway
Senior Microbiologist
Dublin
Senior R&D Engineer
Dublin
Learning Systems Lead
Limerick
R&D Director
Galway
Manufacturing Technician
Clare
QA Engineer
Leitrim
Quality Engineer
Galway
R&D Technician II
Galway
CTO
Galway
CTO
Dublin
Health & Safety Specialist
Dublin
Director of R&D
Limerick
Quality Specialist
Clare
R&D Director
Galway
Project Engineer
Clare
R&D Engineer
Dublin
QC Bioanalytical Sciences - Senior Assoc
Dublin
Quality Assurance Engineer
Longford
Validation Engineer
Carlow
Project Manager
Kildare
Senior Quality Control Associate
Dublin South
Process Chemist
Limerick
Senior Project Manager - Fill Finish
Dublin
Quality Specialist
Tipperary
Senior R&D Engineer
Clare
Production Operator
Meath
Electrical Technician
Limerick
Senior Research and Development Engineer
Galway
Senior QC Associate (Bioassay)
Dublin
Senior Manufacturing Process Specialist
Cork
Senior Equipment Design Engineer
Dublin
Principal R&D Engineer
Galway
Senior R&D Engineer
Galway
R&D Engineer
Galway
Quality Engineer
Athlone
Quality Assurance Associate
Cork
Senior QC Micro Analyst
Cork
Principal R&D Engineer
Dublin
Senior Manufacturing Engineer
Galway City
Quality Manager
Galway
Project Manager (Pharma)
Dublin
Senior Regulatory Affairs Specialist
Athlone
Technical Life Cycle & Engineering M
Galway
Mechanical Technician
Carlow
Senior Product Development Engineer
Galway
Documentation Specialist
Louth
Senior Manufacturing Engineer
Galway
Quality Manager - NPI
Dublin
R&D Engineer
Galway
Senior Quality Engineer
Galway
R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Senior Regulatory Affairs Manager
Galway
Project Engineer
Roscommon
Senior Process Development Engineer
Galway
Regulatory Affairs Maanger
Galway
R&D Engineer
Clare
Sr Project Manager - Syringe Fill Engine
Dublin
Reg Affairs Specialist
Connaught
Senior Product Development Engineer
Galway
Advanced Technologies R&D Manager
Clare
Principal Reliability Engineer
Galway
Senior Quality Engineer
Dublin
Warehouse Operator
Meath
Supply Chain Project Manager (hybrid)
Dublin
Design Assurance Engineer
Galway
Design Assurance Program Manager
Galway
Microbiology Manager
Dublin
Quality Control Analyst (shift)
Carlow
QC Instrumentation Specialist
Dublin
Purchasing & Planning Manager
Wexford
Senior R&D Engineer
Galway
Quality Engineer - Supplier
Galway
R&D Manager
Athlone
R&D Manager
Connaught
Principal Engineer
Dublin
Senior Design Assurance Engineer
Galway
Quality Assurance Team Lead
Cork
Engineering Support Specialist
Louth
Quality Specialist
Clare
Senior Electronic Engineer
Dublin
Product Specialist - Orthopaedic Divisio
Dublin
Senior Design Assurance Engineer
Galway
Senior Research & Development Engine
Limerick
R&D Manager
Galway
Director Engineering & Supply Chain
Galway
Business Development Manager
Republic of Ireland
Senior Design Engineer
Dublin
R&D Manager
Galway
Quality Manager
Galway
Design Quality Engineer
Galway
Senior R&D Engineer
Dublin
Regulatory Affairs Specialist
Cork
Principal Process Equipment Engineer
Dublin South
Senior Regulatory Affairs Specialist
Athlone
Quality Specialist
Clare
Project Manager
Kildare
Shift Technician (Injection Moulding)
Kildare
Quality Engineer
Galway
Quality Assurance Specialist/Manager
Dublin
Equipment Engineer (Formulation, Autocla
Dublin
Senior Quality Engineer
Leitrim
R&D Engineer
Galway
Senior QA Associate (shift)
Dublin
Senior Associate Quality Control (Shift)
Dublin
Senior Quality Assurance Specialist
Cork
Sales/Customer Service Administrator
Clonmel
Project Manager - New Product Introducti
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Senior Regulatory Affairs Specialist
Clare
Product Specialist (Endoscopy)
Dublin
Product Development Technician II
Galway
Clinical Trial Manager
Republic of Ireland
Commercial Solutions Manager (Medical De
Dublin
Senior Manufacting Engineer
Republic of Ireland
Senior R&D Manager - Lifecycle Manag
Galway
Senior QC Micro Analyst
Cork
R&D Engineer
Galway
Principal R&D Engineer
Dublin
Technical Support Specialist - Drug Subs
Louth
Principal R&D Engineer
Galway
Operations Engineer
Galway
R&D Engineer
Dublin
Injection Moulding Engineer
Leitrim
Manufacturing Technician
Galway
Quality Assurance Senior Specialist
Louth
Senior Equipment Design Engineer
Dublin
Product Development Engineer
Galway
Technical Transfer Specialist - Remote
Republic of Ireland
Quality Technician
Dublin
Product Development Engineer
Dublin
R&D Director
Galway
R&D Engineer
Galway
Senior Maintenance Technician
Roscommon
QA Manager
Canada
Production Manager
Dublin
Process Engineer
Carlow
Health & Safety Specialist
Louth
Supplier Quality Engineer
Galway
R&D Manager
Galway
Sr Principal R&D Engineer
Galway
Senior Equipment Design Engineer
Dublin
Injection Moulding Engineer
Athlone
R&D Manager
Connaught
Analytical Chemist
Tipperary
Senior R&D Manager
Athlone
Senior Quality Engineer
Galway
R&D Manager
Galway
Senior Electronic Engineer
Dublin
CQV /CSV Quality Assurance Specialist (H
Dublin
NPI Engineer - Hybrid
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Senior Electronic Engineer
Dublin
Senior Design Assurance Engineer
Galway
Senior Maintenance Technician
Kilkenny
Calibration Technician
Republic of Ireland
Quality Engineer
Athlone
Injection Moulding Engineer
Athlone
R&D Manager
Galway
Manufacturing Technician
Clare
Engineering Support 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