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 Engineer
Galway
Manufacturing Engineer
Cork
R&D Manager
Connaught
R&D Program Manager
Dublin
R&D Manager
Galway
Quality Manager - NPI
Dublin
Technical Life Cycle & Engineering M
Galway
Quality Engineer
Galway
Senior R&D Engineer
Galway
Senior R&D Engineer - Sustaining
Galway
R&D Engineer
Galway
Senior Project Engineer
Cavan
Project Engineer
Roscommon
Technical Marketing Manager
Wexford
Quality Assurance Specialist (Logistics)
Dublin
QC Bioanalytical Sciences - Senior Assoc
Dublin
Sr Electrical Engineer
Galway
Project Manager (hybrid)
Dublin
R&D Engineer
Galway
Senior R&D Engineer
Galway
Principal Engineer
Dublin
Principal R&D Engineer
Galway
Senior R&D Engineer
Galway
Principal R&D Engineer
Galway
Senior Quality Control Associate
Dublin South
Senior Quality Engineer
Leitrim
Design Assurance Engineer
Galway
Senior Regulatory Specialist
Cork
Senior Quality Engineer
Dublin
R&D Manager
Dublin
Maintenance CMMS Engineer
Tipperary
Software Design Assurance Engineer
Dublin
Sr Electrical Engineer
Galway
Senior R&D Engineer
Galway
Project Manager - R&D
Galway
Manufacturing Technician
Galway
Injection Moulding Engineer
Athlone
Change Control SME
Cork
Project Engineer
Louth
Lead Maintenance Reliability Engineer
Westmeath
Staff R&D Engineer
Limerick
Senior R&D Engineer
Galway
R&D Engineer
Galway
Senior Process Engineer
Galway
Project Manager
Kildare
Senior R&D Manager
Athlone
Product Development Engineer II
Athlone
Process Engineer
Galway
Manufacturing Engineer
Galway
Senior Recruitment Consultant
Republic of Ireland
Regulatory Affairs Maanger
Galway
Manufacturing Engineer
Galway
Product Development Engineer
Dublin
Production Operator
Carlow
Quality Systems Manager
Dublin
R&D Manager
Athlone
Embedded Software Engineer
Dublin
Senior Manufacting Engineer
Republic of Ireland
(Senior) Manufacturing Engineers - Globa
Limerick
R&D Engineer
Dublin
Senior Manufacturing Engineer
Galway
QA Engineer
Leitrim
Electronic Engineering
Dublin
Cleaning Validation Specialist
Cork
R&D Director
Galway
Quality Technician
Dublin
Clinical Research Associate
Cork
Product Development Engineer
Galway
Electronic Engineer
Dublin
Principal R&D Engineer
Galway
Project Manager Design Assurance
Galway
R&D Manager
Galway
R&D Engineer
Galway
Principal R&D Engineer
Dublin
R&D Engineer
Galway
Quality Engineer
Galway
Project Manager
Louth
CTO
Dublin
R&D Manager
Galway
Senior R&D Engineer
Galway
Senior R&D Engineer
Galway
R&D Manager
Connaught
Senior Regulatory Specialist
Cork
R&D Manager
Connaught
Senior QC Associate
Dublin
R&D Technician II
Galway
Principal R&D Engineer
Galway
Quality Technician
Dublin
Clinical Research Manager
Cork
CTO
Galway
Quality Specialist
Clare
Biomedical Engineer
Dublin
Quality Manager
Galway
Maintenance & Reliability Technician
Limerick
Project Engineer
Cork
Senior R&D Engineer
Dublin
Electronic Engineer
Dublin
Project Engineer
Limerick
Senior R&D Engineer
Galway
Sr R&D Manager
Galway
Senior R&D Engineer
Clare
Maintenance & Reliability Technician
Limerick
QA Manager
Canada
Principal Engineer
Dublin
Senior Principal Design and Development
Galway
Product Development Engineer
Dublin
R&D Engineer
Galway
Senior R&D Engineer
Galway
Principal Design and Development Enginee
Galway
R&D Manager
Galway
Quality Engineer
Athlone
Production Manager
Dublin
Principal R&D Engineer
Galway
R&D Director
Galway
Lead Maintenance Technician
Kilkenny
Biomedical Engineer
Dublin
Mechanical Technician
Carlow
Senior R&D Manager - Lifecycle Manag
Galway
Microbiology Manager
Dublin
Senior Electronic Engineer
Dublin
Project Manager - New Product Introducti
Dublin
Quality Engineer
Galway
Senior Maintenance Technician
Kilkenny
Calibration Technician
Republic of Ireland
Manufacturing Technician
Clare
Senior Regulatory Affairs Specialist
Athlone
Senior R&D Engineer
Galway
R&D Engineer
Galway
Learning Systems Lead
Limerick
Principal R&D Engineer
Galway
Senior Quality Engineer
Dublin
Injection Moulding Engineer
Leitrim
Quality Specialist
Tipperary
Product Development Technician II
Galway
Advanced Technologies R&D Manager
Clare
Senior Process Development Engineer
Galway
Senior Maintenance Technician
Kilkenny
Senior Design Assurance Engineer
Galway
Project Manager
Kildare
Product Specialist (Peripheral Endovascu
Dublin
Process Engineer
Roscommon
Utilities Engineer
Dublin
Senior Quality Engineer
Dublin
Director of Regulatory Affairs
Galway
Operational Excellence Specialist
Cork
Senior R&D Engineer
Dublin
Manufacturing Technician
Clare
Senior R&D Engineer
Galway
Principal R&D Engineer
Dublin
Production Operator
Meath
Manufacturing Technician
Clare
Quality Manager - Medical Devices
Limerick City
Project Manager - R&D
Galway
Process Chemist
Limerick
Senior Regulatory Affairs Specialist
Athlone
Mechanical Technician - 2 Cycle
Carlow
Regulatory Specialist
Galway
Engineering Shift Technician
Dublin
Senior R&D Engineer
Galway
Project Manager Design Assurance
Galway
Quality Engineer
Galway
Product Development Technician II
Galway
Manufacturing Technician
Galway
Quality Manager
Dublin
Senior Associate Quality Control (Shift)
Dublin
Senior Process Engineer
Dublin
Electronic Engineer
Dublin
Maintenance Technician
Kilkenny
Pharmacovigilance Manager (Remote)
Republic of Ireland
Shift Technician (Injection Moulding)
Kildare
Continuous Improvement Coach
Limerick
R&D Director
Galway
R&D Manager
Galway
R&D Engineer
Galway
Mechanical Engineer
Dublin
R&D Manager
Athlone
R&D Technician II
Galway
R&D Engineer
Dublin
Principal Quality Engineer
Galway
R&D Director
Galway
Advanced Technologies Manager
Galway
Senior Project Engineer
Cavan
Principal R&D Engineer
Galway
Growth Manager (Healthcare)
Dublin
Senior Quality Engineer
Galway
R&D Engineer
Clare
Quality Assurance Engineer
Longford
Senior R&D Engineer
Dublin
Business Development Manager (Pharma &am
Republic of Ireland
Product Development Engineer
Dublin
Process Development Engineer
Galway
Regulatory Affairs Associate
Cork
Quality Technician
Dublin
R&D Engineer
Galway
Quality Engineer
Wexford
Documentation Specialist
Louth
R&D Technician
Galway
Quality Engineer
Galway
Senior R&D Engineer
Galway
R&D Engineer
Galway
Principal Process Equipment Engineer
Dublin South
Senior Electronic Engineer
Dublin
Senior Quality Systems Engineer
Galway
Associate Director - Manufacturing &
Limerick
R&D Manager
Connaught
Quality Assurance Senior Specialist
Louth
Senior Recruitment Consultant
Republic of Ireland
Senior Maintenance Technician
Kilkenny
Territory Manager (Woundcare)
Cork
Maintenance Manufacturing Technician
Kilkenny
Senior Mechanical Engineer
Dublin
Reliability Engineering Consultant - Rem
Republic of Ireland
Maintenance Reliability Engineer
Cork
Injection Molding Engineer
North Leinster
Senior Electronic Engineer - Regulated M
Galway
Project Manager
Galway
Director Engineering & Supply Chain
Galway
Senior Associate Quality Control
Dublin
Sales/Customer Service Administrator
Clonmel
Senior Electronics Engineer
Dublin
Responsible Person (RP)
Republic of Ireland
Senior Operations Engineer
Galway
Health & Safety Specialist
Dublin
Manufacturing Technician
Clare
Injection Molding Engineer
North Leinster
Associate Analytical Scientist
Meath
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:JCAO0424 Location: Galway
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs Director

Director of Regulatory Affairs – Medical Device Start-Up – Galway

About the Company
Our client is an ambitious, well-funded medical device start-up based in Galway, entering a critical phase of operational expansion. Backed by a proven management team with a strong track record in the start-up sector, the company is primed for significant growth both domestically and internationally.

The Opportunity
We are seeking a Director of Regulatory Affairs with a strong strategic vision and leadership capability to join the executive team. This is a key role where you will define and lead the company’s global regulatory strategy, ensuring successful approvals and market access as the business scales rapidly.

Key Responsibilities

  • Develop and drive global regulatory strategies to support product development, commercialization, and market expansion activities.
  • Manage all regulatory submissions (CE marking, FDA 510(k)/PMA, and other global submissions) and ensure alignment with commercial and operational timelines.
  • Serve as the primary liaison with regulatory authorities, representing the company in all regulatory interactions and negotiations.
  • Build and lead a high-performing regulatory team to support both early-stage product development and later-stage market access activities.
  • Monitor and interpret evolving regulatory requirements to ensure proactive compliance across multiple geographies.
  • Collaborate closely with cross-functional teams including R&D, Quality, Clinical, and Commercial to integrate regulatory requirements into project plans and strategic decision-making.
  • Support due diligence and partnership activities through regulatory assessments and strategy development.
About You
  • Minimum of 10 years’ experience in Regulatory Affairs within the medical device industry, with at least 3 years in a leadership role.
  • Proven success in preparing and leading regulatory submissions for Class II/III devices (EU MDR and FDA pathways essential).
  • Strong understanding of the global regulatory environment, including emerging markets.
  • Ability to think strategically while executing detailed regulatory plans.
  • Exceptional leadership, communication, and stakeholder management skills.
  • Comfortable operating in a fast-paced, high-growth, entrepreneurial environment.
  • Degree in Life Sciences, Engineering, Regulatory Affairs, or a related technical field; Regulatory Affairs Certification (RAC) is advantageous.
What’s on Offer
  • The chance to be a key architect of the company’s regulatory success during an exciting growth phase.
  • A senior leadership role with real influence across the business.
  • Competitive salary, equity participation, and an attractive benefits package.
  • An entrepreneurial, high-energy culture with a leadership team known for successful start-up growth and exits.
If interested in discussing further please contact James Cassidy [email protected] or call in confidence 086 0204322