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
R&D Manager
Galway
Application Software Engineer
Galway
Senior R&D Engineer
Dublin
R&D Engineer
Galway
Advanced Technologies Manager
Galway
R&D Engineer
Clare
Product Development Engineer
Dublin
Process Engineer Specialist
Carlow
Regulatory Affairs Specialist
Cork
Bioprocess Associate
Louth
R&D Engineer
Galway
R&D Project Manager
Galway
Senior Quality Engineer
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Principal Engineer
Dublin
R&D Manager
Athlone
R&D Engineer
Galway
Senior Equipment Design Engineer
Dublin
Business Excellence Lead (Manufacturing)
Wexford
Senior R&D Manager - Lifecycle Manag
Galway
Principal Instrumentation & Calibrat
Limerick
Senior QC Associate
Dublin
Staff Systems Engineer
Limerick
Quality Assurance Senior Specialist
Louth
Biomedical Engineer
Dublin
Engineering Shift Technician
Dublin
Quality Specialist
Tipperary
Senior Regulatory Affairs Specialist
Athlone
Product Development Technician II
Galway
Senior Regulatory Affairs Specialist
Athlone
R&D Engineer
Dublin
Project Engineer
Republic of Ireland
Product Development Engineer II
Athlone
Quality Assurance Engineer
Longford
Senior Principal Design and Development
Galway
Project Engineer
Clare
Project Manager
Galway
R&D Engineer
Galway
Senior R&D Engineer
Clare
Inside Sales Representative (IVD Divisio
Kildare
Senior Maintenance Technician
Kilkenny
Quality Assurance Specialist (hybrid)
Dublin
Product Development Engineer II
Athlone
Senior Regulatory Affairs Manager
Galway
R&D Engineer
Galway
Injection Molding Engineer
North Leinster
R&D Manager
Galway
R&D Manager
Connaught
Principal Quality Engineer
Galway
Purchasing & Planning Manager
Wexford
Policy Analyst (Pharmaceutical)
Dublin
Senior R&D Engineer
Galway
Product Development Engineer
Dublin
Senior Electronic Engineer
Dublin
Business Development Manager (Pharma &am
Republic of Ireland
Sales/Customer Service Administrator
Clonmel
Technical Transfer Specialist - Remote
Republic of Ireland
Principal R&D Engineer
Dublin
Quality Engineer
Wexford
Design Assurance Engineer
Clare
Senior R&D Engineer
Galway
Senior Quality Control Associate
Dublin South
R&D Engineer
Galway
Senior Principal R&D Engineer
Galway
Quality Manager
Galway
Product Development Engineer
Dublin
R&D Engineer
Galway
Engineering Business Manager
Dublin
Product Development Engineer
Dublin
Senior Regulatory Affairs Specialist
Dublin
Process Chemist
Limerick
Project Manager - R&D
Galway
Senior R&D Engineer
Galway
Senior Maintenance Technician
Kilkenny
Senior Quality Engineer
Dublin
R&D Manager
Connaught
Principal R&D Engineer
Galway
Sr Principal R&D Engineer
Galway
Manufacturing Technician
Clare
Microbiology Manager
Dublin
Engineering Support Specialist
Louth
Advanced Technologies R&D Manager
Clare
Manufacturing Technician
Clare
Senior Quality Engineer
Dublin
Senior R&D Engineer
Galway
Commercial Attribute Science Snr Associa
Dublin
Manufacturing Technician
Clare
Validation & Verification Engineer
Dublin
Warehouse Operator
Meath
R&D Manager
Galway
Principal R&D Engineer
Galway City
Senior Project Engineer
Cavan
Director of R&D
Limerick
Quality Manager
Galway
Project Manager - New Product Introducti
Dublin
QA Manager
Canada
Senior Equipment Design Engineer
Dublin
Senior Research & Development Engine
Limerick
Senior R&D Engineer
Clare
Quality Specialist - Quality Management
Dublin
Project Engineer
Roscommon
R&D Manager
Athlone
Product Specialist (Endoscopy)
Dublin
Senior Regulatory Specialist
Cork
Senior R&D Engineer
Galway
Senior Quality Systems Engineer
Galway
Senior Design Assurance Engineer
Athlone
Senior Design Engineer
Dublin
Documentation Specialist
Louth
Quality Specialist
Clare
R&D Manager
Connaught
Quality Assurance Team Lead
Cork
R&D Engineer
Galway
Continuous Improvement Coach
Limerick
R&D Director
Galway
Learning Systems Lead
Limerick
Maintenance & Reliability Technician
Limerick
Biomedical Engineer
Dublin
Sr Electrical Engineer
Galway
Advanced Technologies R&D Manager
Clare
Senior R&D Engineer
Galway
Design Assurance Engineer
Clare
Senior Electronic Engineer
Dublin
Clinical Seating Specialist - Primary Ca
Dublin
Quality Engineer
Galway
Principal Software Engineer
Athlone
CTO
Galway
Senior R&D Engineer
Galway
Senior Quality Engineer
Leitrim
Principal Engineer
Dublin
Strategic Automation Lead
Waterford
Mechanical Engineer
Dublin
Senior Quality Engineer
Dublin
Senior R&D Engineer
Dublin
Quality Technician
Dublin
Senior R&D Engineer
Galway
Manufacturing Technician
Clare
Manufacturing Engineer
Galway
Senior R&D Engineer II
Galway
R&D Engineer
Galway
Quality Assurance Specialist (shift)
Carlow
Senior Regulatory Affairs Manager
Galway
Supply Chain Project Manager (hybrid)
Dublin
Electronic Engineer
Dublin
Embedded Software Engineer
Dublin
Quality Assurance Specialist (shift)
Carlow
Senior Quality Systems Engineer
Galway
Senior R&D Engineer
Galway
Senior Regulatroy Affairs Specialsit
Galway
Senior Product Development Engineer
Galway
Business Development Manager (Pharma &am
Republic of Ireland
Senior Operations Engineer
Galway
R&D Engineer
Galway
Senior R&D Engineer
Dublin
Senior R&D Engineer
Galway
R&D Engineer
Dublin
Manufacturing Technician
Galway
Senior R&D Engineer-New Product Deve
Westmeath
QA Engineer
Leitrim
Responsible Person (RP)
Republic of Ireland
Regulatory Affairs Maanger
Galway
Quality Assurance Specialist/Manager
Dublin
Quality Manager - Medical Devices
Limerick City
Senior Electronic Engineer - Regulated M
Galway
Project Manager Design Assurance
Galway
Regulatory Affairs Manager - Senior
Galway
Quality Manager
Dublin
Senior R&D Engineer
Galway
Product Development Engineer
Galway
R&D Engineer
Galway
Project Manager
Kildare
Shift Technician (Injection Moulding)
Kildare
R&D Manager
Galway
Project Manager
Kildare
Senior Microbiologist
Dublin
Senior Quality Engineer
Leitrim
Senior Equipment Design Engineer
Dublin
R&D Manager
Connaught
Senior Manufacturing Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Technical Marketing Manager
Wexford
Senior Design Assurance Engineer
Galway
Calibration Technician
Republic of Ireland
Quality Engineer
Galway
R&D Technician II
Galway
Product Development Manager
Galway
R&D Manager
Dublin
Reg Affairs Specialist
Connaught
Technical Life Cycle & Engineering M
Galway
R&D Manager
Galway
CTO
Dublin
Principal R&D Engineer
Galway
Injection Moulding Engineer
Athlone
Project Manager Design Assurance
Galway
Senior Regulatory Affairs Specialist
Westmeath
Project Manager - R&D
Galway
Senior Manufacturing Engineer
Galway City
Senior Manufacting Engineer
Republic of Ireland
Purchasing & Planning Manager
Wexford
Cleaning Validation Engineer
Republic of Ireland
Senior R&D Manager - Lifecycle Manag
Galway
Project Engineer - Senior
Cavan
Quality Assurance Specialist (Logistics)
Dublin
Process Engineer
Carlow
Senior Regulatory Affairs Manager
Galway
Quality Engineer
Galway
Product Development Engineer II
Athlone
R&D Director
Galway
Senior QC Associate
Dublin
Quality Manager
Dublin
Operations Engineer
Galway
Validation Engineer
Republic of Ireland
Senior R&D Engineer
Galway
Principal R&D Engineer
Galway
Quality Engineer
Galway
R&D Director
Galway
Quality Engineer
Athlone
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