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 Director
Galway
Quality Specialist
Clare
R&D Engineer
Galway
Senior Quality Engineer
Dublin
Senior Design Assurance Engineer
Galway
Continuous Improvement Coach
Limerick
Supplier Quality Engineer
Galway
Biomedical Engineer
Dublin
Quality Manager
Dublin
R&D Lifecycle Manager
Connaught
Senior R&D Engineer
Galway
R&D Technician II
Galway
CTO
Galway
Senior Product Development Engineer
Galway
Sterilisation Manager
Tipperary
Quality Assurance Specialist (Hybrid)
Dublin
Senior Research & Development Engine
Limerick
Senior R&D Engineer
Galway
Purchasing & Planning Manager
Wexford
Principal Design and Development Enginee
Galway
Senior Electronic Engineer
Dublin
Quality Manager - Medical Devices
Limerick City
Quality Assurance Specialist (Logistics)
Dublin
Senior Quality Systems Engineer
Galway
Business Manager (Critical Care & Me
Dublin
Senior QC Systems Validation Associate
Dublin
Senior QC Micro Analyst
Cork
Software Design Assurance Engineer
Dublin
Senior R&D Engineer
Clare
Project Engineer
Roscommon
R&D Manager
Dublin
Quality Manager
Dublin
Product Development Engineer II
Athlone
R&D Manager
Galway
Principal R&D Engineer
Galway
Principal Process Equipment Engineer
Dublin South
R&D Director
Galway
Quality Assurance Specialist (shift)
Carlow
Project Manager
Kildare
Senior Microbiologist
Dublin
Senior Electronics Engineer
Dublin
R&D Program Manager
Dublin
Electrical Condition Monitoring Technici
Limerick
Production Manager
Dublin
Senior Manufacturing Specialist
Dublin
R&D Manager
Galway
Quality Specialist
Clare
Director of R&D
Limerick
Senior Design Assurance Engineer
Galway
Continuous Improvement Coach
Limerick
Senior QA Associate (shift)
Dublin
Sterilisation Manager
Tipperary
R&D Engineer
Galway
Senior R&D Engineer
Dublin
R&D Manager
Galway
Senior R&D Engineer
Galway
R&D Engineer
Galway
Tech Transfer Lead - Sterile Drug Produc
Dublin
Senior QC Associate
Dublin
Advanced Technologies Manager
Galway
Process Chemist
Limerick
Senior Project Engineer
Dublin
Responsible Person (RP)
Republic of Ireland
Senior Associate Quality Control
Dublin
Senior Reg Affairs Specialist - Post Mar
Galway
Microbiology Manager
Dublin
Product Specialist (Critical Care &
Dublin
Product Specialist (Endoscopy)
Dublin
Engineering Shift Technician
Dublin
Design Assurance Engineer
Galway
Senior Validation Engineer - HVAC
Dublin
Senior Process Engineer - DP or DS
Dublin
Senior Electronic Engineer
Dublin
Quality Assurance Specialist (hybrid)
Dublin
Quality Engineer - Supplier
Galway
R&D Manager
Galway
R&D Engineer
Dublin
R&D Engineer
Dublin
Equipment Engineer (Formulation, Autocla
Dublin
R&D Manager
Connaught
Director Engineering & Supply Chain
Galway
Senior Regulatroy Affairs Specialsit
Galway
Senior Regulatory Affairs Specialist
Athlone
Project Engineer - Senior
Cavan
Project Manager
Kildare
R&D Manager
Connaught
Operations Engineer
Galway
Validation & Verification Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Senior Quality Engineer
Leitrim
Quality Assurance Team Lead
Cork
Business Development Manager (Hospitals)
Cork
Quality Assurance Manager
Dublin
Senior Maintenance Technician
Kilkenny
Staff Systems Engineer
Limerick
R&D Technician II
Galway
Business Development Manager (Hospitals)
Cork
Product Development Manager
Galway
Sr Project Manager - Syringe Fill Engine
Dublin
QA Manager
Canada
R&D Engineer
Galway
R&D Manager
Athlone
Senior R&D Manager
Athlone
Senior R&D Engineer
Galway
Senior Equipment Design Engineer
Dublin
Senior Regulatory Affairs Specialist
Clare
R&D Manager
Galway
QC Instrumentation Specialist
Dublin
Regulatory Affairs Maanger
Galway
Senior Process Engineer
Longford
Design Quality Engineer
Galway
Senior R&D Engineer
Galway
Principal Engineer
Dublin
Injection Molding Engineer
North Leinster
Project Engineer
Clare
Clinical Trial Manager
Republic of Ireland
Senior Electronic Engineer - Regulated M
Galway
Senior NPI Engineer - Hybrid
Dublin
Manufacturing Engineer
Galway
Technical Life Cycle & Engineering M
Galway
Purchasing & Planning Manager
Wexford
Project Manager
Galway
Technical Support Specialist - Drug Subs
Louth
Senior R&D Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Engineering Business Manager
Dublin
Documentation Specialist
Louth
Injection Moulding Engineer
Athlone
Manufacturing Technician
Galway
Senior Design Engineer
Dublin
Senior Quality Engineer
Leitrim
Sales/Customer Service Administrator
Clonmel
Senior Maintenance Technician
Roscommon
Director of Regulatory Affairs
Galway
Principal Device Engineer
Dublin
Graduate Occupational Hygiene Consultant
Kildare
Principal Design Assurance Engineer
Galway
QC Micro Analyst (4 cycle shift)
Cork
Senior Project Engineer
Cavan
Reg Affairs Specialist
Connaught
R&D Engineer
Clare
Engineering Support Specialist
Louth
Principal Engineer
Dublin
R&D Engineer
Galway
Product Development Engineer
Galway
Health & Safety Specialist
Dublin
Project Manager - R&D
Galway
Senior Quality Engineer
Dublin
CTO
Dublin
Documentation Specialist
Louth
Principal R&D Engineer
Galway
Quality Technician
Dublin
Strategic Automation Lead
Waterford
Electronic Engineering
Dublin
Quality Manager
Galway
Quality Manager - NPI
Dublin
Quality Specialist
Tipperary
Sterilisation Manager
Tipperary
R&D Manager
Connaught
Product Development Engineer
Galway
Quality Engineer - Supplier
Galway
Product Development Engineer
Dublin
Quality Technician
Dublin
Principal R&D Engineer
Galway
Business Development Manager
Republic of Ireland
Senior Quality Engineer
Dublin
Senior Operations Engineer
Galway
R&D Manager
Athlone
Continuous Improvement Coach
Limerick
Maintenance & Reliability Technician
Limerick
Quality Assurance Specialist (shift)
Carlow
Senior Process Engineer
Dublin
Director of R&D
Clare
Senior Equipment Design Engineer
Dublin
Senior Quality Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Quality Engineer
Galway
Manufacturing Specialist - Investigation
Dublin
Quality Control Analyst (shift)
Carlow
Senior Design Assurance Engineer
Galway
Health & Safety Specialist
Louth
CQV /CSV Quality Assurance Specialist (H
Dublin
Advanced Technologies R&D Manager
Clare
Senior QC Microbiology
Dublin
Supply Chain Specialist
Galway
Quality Engineer
Athlone
Principal R&D Engineer
Dublin
R&D Director
Galway
Senior Associate Quality Control (Shift)
Dublin
Senior Quality Engineer
Dublin
Commercial Solutions Manager (Medical De
Dublin
Calibration Technician
Republic of Ireland
Principal R&D Engineer
Dublin
Accreditation Manager
Republic of Ireland
CQV Engineer
Dublin
QA Technical Support Specialist
Dublin
Senior Manufacturing Engineer
Galway
Senior R&D Engineer
Clare
R&D Manager
Connaught
Senior Research and Development Engineer
Galway
Application Software Engineer
Galway
Injection Moulding Engineer
Athlone
Maintenance & Reliability Technician
Limerick
Senior Manufacting Engineer
Republic of Ireland
Senior R&D Engineer
Dublin
R&D Engineer
Galway
QA Engineer
Leitrim
Dental- Manager/ Senior Manager Business
Republic of Ireland
R&D Engineer
Galway
Injection Moulding Engineer
Athlone
Commercial Attribute Science Snr Associa
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Change Control Specialist
Tipperary
Senior Contract Development & Manufa
Dublin
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