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
QA Engineer
Leitrim
Senior Design Assurance Engineer
Galway
Principal Design Assurance Engineer
Galway
Principal Reliability Engineer
Galway
Production Operator
Meath
R&D Manager
Galway
Senior R&D Engineer
Dublin
Injection Moulding Engineer
Leitrim
R&D Director
Galway
Quality Technician
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Principal Engineer
Dublin
Product Specialist (Critical Care &
Dublin
Senior Regulatory Affairs Specialist
Clare
Senior Associate Quality Control
Dublin
Senior R&D Engineer
Dublin
R&D Engineer
Galway
Director of Regulatory Affairs
Galway
Senior Regulatory Affairs Specialist
Athlone
Senior R&D Engineer II
Galway
LIMS Specialist
Tipperary
Senior Quality Engineer
Dublin
R&D Manager
Galway
Engineering Shift Technician
Dublin
Quality Manager - Medical Devices
Limerick City
Manufacturing Technician
Clare
Senior Quality Engineer
Leitrim
Senior Operations Engineer
Galway
Quality Engineer
Wexford
R&D Manager
Connaught
Supply Chain Project Manager (hybrid)
Dublin
Director of R&D
Limerick
Senior R&D Engineer
Galway
Quality Assurance Specialist (hybrid)
Dublin
R&D Engineer
Dublin
Senior Design Engineer
Dublin
Manufacturing Specialist (Investigation
Dublin
R&D Engineer
Galway
Senior Quality Engineer
Dublin
Manufacturing Specialist - Investigation
Dublin
Director Engineering & Supply Chain
Galway
Senior Mechanical Engineer
Dublin
Quality Engineer
Galway
Quality Specialist
Dublin
Senior Regulatroy Affairs Specialsit
Galway
Lead MSAT Validation Consultant
Republic of Ireland
Sr Project Manager - Syringe Fill Engine
Dublin
R&D Director
Galway
Supplier Quality Engineer
Galway
Product Development Engineer II
Athlone
Senior Equipment Design Engineer
Dublin
Injection Moulding Engineer
Athlone
Validation Engineer
Republic of Ireland
R&D Manager
Connaught
R&D Senior Program Manager
Galway
Quality Specialist
Tipperary
Quality Assurance Team Lead
Cork
Senior Quality Engineer
Dublin
Senior Electronics Engineer
Dublin
Senior Specialist MS&T
Dublin
Senior QC Microbiology
Dublin
Senior Equipment Engineer
Dublin
R&D Technician
Galway
R&D Manager
Galway
Senior Regulatory Affairs Manager
Galway
Senior Design Assurance Engineer
Galway
Senior R&D Engineer
Galway
Senior Design Assurance Engineer
Galway
Technical Life Cycle & Engineering M
Galway
Injection Moulding Engineer
Athlone
Senior R&D Engineer
Galway
QA Specialist (Investigation Lead)
Dublin
Quality Assurance Specialist (shift)
Carlow
Project Engineer
Clare
R&D Engineer
Galway
Senior R&D Engineer
Dublin
Senior Quality Assurance Specialist
Cork
Quality Specialist
Clare
Senior Regulatory Affairs Specialist
Dublin
Project Manager
Kildare
Senior Quality Assurance Associate
Dublin
Validation & Verification Engineer
Dublin
Senior Project Engineer
Cavan
Quality Assurance Specialist (shift)
Carlow
Engineering Business Manager
Dublin
Quality Assurance Specialist (Hybrid)
Dublin
Senior QC Microbiology
Dublin
Quality Manager
Galway
Design Assurance Program Manager
Galway
R&D Engineer
Galway
R&D Manager
Connaught
Senior R&D Engineer
Galway
Key Account Manager - Retail UK National
South East
Health & Safety Specialist
Dublin
R&D Manager
Connaught
Quality Engineer
Galway
R&D Manager
Athlone
Documentation Specialist
Louth
Commercial Solutions Manager (Medical De
Dublin
Director of R&D
Clare
Product Development Engineer
Dublin
Principal Process Equipment Engineer
Dublin South
CTO
Dublin
Quality Manager
Galway
Project Engineer
Roscommon
Quality Manager - NPI
Dublin
QA Manager
Canada
Quality Assurance Senior Specialist
Louth
Tech Transfer Lead - Sterile Drug Produc
Dublin
Senior Quality Systems Engineer
Galway
R&D Manager
Galway
Manufacturing Technician
Clare
Senior Electronic Engineer
Dublin
Application Software Engineer
Galway
Part time Opportunity-Senior QA Speciali
Dublin
R&D Manager
Dublin
CTO
Galway
R&D Engineer
Galway
Senior R&D Manager
Athlone
QC Specialist
Cork
Senior Regulatory Specialist
Cork
Senior Quality Control Associate
Dublin South
Quality Assurance Team Lead
Cork
Senior Maintenance Technician
Kilkenny
Senior Quality Engineer
Leitrim
Senior Quality Engineer
Dublin
Senior Quality Engineer
Galway
Design Quality Engineer
Galway
Regulatory Affairs Maanger
Galway
Principal R&D Engineer
Galway
R&D Engineer
Clare
Product Development Manager
Galway
Quality Technician
Dublin
Director of Regulatory Affairs
Galway
Product Development Engineer
Dublin
Validation Engineer
Carlow
Senior Manufacting Engineer
Republic of Ireland
Calibration Technician
Republic of Ireland
Technical Life Cycle & Engineering M
Galway
R&D Engineer
Galway
Senior Regulatory Specialist
Cork
QA Operations Specialist
Dublin
Senior Process Development Engineer
Dublin
Senior QC Specialist - Equipment & I
Dublin
Quality Engineer
Galway
Responsible Person (RP)
Republic of Ireland
Senior QC Microbiology
Dublin
Shift Technician (Injection Moulding)
Kildare
Senior Quality Assurance Associate
Dublin
Manufacturing Technician
Clare
R&D Engineer
Galway
Quality Assurance Specialist/Manager
Dublin
Senior Electronic Engineer - Regulated M
Galway
Senior R&D Engineer
Galway
QA Quality Systems Specialist
Dublin
Quality Technician
Dublin
Senior QA Specialist
Dublin
Senior Process Engineer - DP or DS
Dublin
Project Engineer
Cork
Business Development Manager
Republic of Ireland
R&D Director
Galway
Senior Quality Engineer
Dublin
Marketing Manager
Galway
Embedded Software Engineer
Dublin
Purchasing & Planning Manager
Wexford
Senior Quality Engineer
Dublin
Senior Quality Assurance Specialist (hyb
Dublin
Quality Engineer
Galway
Principal R&D Engineer
Galway
Mechanical Technician
Carlow
R&D Engineer
Galway
Senior Human Factors Engineer
Galway
Industrial Designer
Galway
Senior Quality Assurance Associate
Dublin
Senior Director of Manufacturing and Sup
Galway
Senior Regulatory Affairs Specialist
Athlone
Operations Manager
Galway
Quality Manager
Galway
Senior Technology Transfer Specialist
Dublin
Quality Manager
Galway
Process Chemist
Limerick
Design Assurance Manager
Galway
Advanced Technologies R&D Manager
Clare
R&D Engineer
Dublin
R&D Manager
Galway
Senior Research and Development Engineer
Galway
Senior Quality Assurance Technical Suppo
Dublin
Advanced Technologies R&D Manager
Clare
Senior R&D Manager
Athlone
R&D Manager
Athlone
Documentation Specialist
Louth
Quality Specialist
Clare
Technical Transfer Specialist - Remote
Republic of Ireland
R&D Director
Galway
Senior Process Engineer
Dublin
Tech Transfer Lead
Dublin
Product Development Engineer
Galway
Senior Equipment Design Engineer
Dublin
Project Manager
Kildare
R&D Lifecycle Manager
Connaught
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