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 Manager
Galway
Senior R&D Engineer II
Galway
Quality Assurance Specialist (shift)
Carlow
Senior Regulatory Affairs Specialist
Westmeath
R&D Engineer
Galway
Senior Quality Engineer
Dublin
Advanced Technologies R&D Manager
Clare
Documentation Specialist
Louth
Technical Life Cycle & Engineering M
Galway
R&D Engineer
Dublin
Manufacturing Technician
Clare
Documentation Specialist
Louth
R&D Technician II
Galway
R&D Engineer
Galway
Senior Commissioning & Qualification
Roscommon
R&D Engineer
Galway
Senior QA Associate (shift)
Dublin
Quality Manager
Galway
Learning Systems Lead
Limerick
Senior Equipment Design Engineer
Dublin
Senior Maintenance Technician
Roscommon
Senior QC Microbiology
Dublin
Senior Process Engineer - DP or DS
Dublin
R&D Manager
Galway
R&D Director
Galway
CTO
Dublin
Senior R&D Engineer
Galway
Senior R&D Manager
Athlone
Senior Electronic Engineer
Dublin
Senior Design Engineer
Dublin
Principal R&D Engineer
Dublin
Senior Process Development Engineer
Galway
Design Quality Engineer
Galway
Dental- Manager/ Senior Manager Business
Republic of Ireland
R&D Manager
Galway
Product Development Engineer
Galway
Analytical Chemist
Tipperary
Senior Project Engineer - R&D
Galway
Lead MSAT Validation Consultant
Republic of Ireland
Pharmacovigilance Manager (Remote)
Republic of Ireland
Construction Manager - Pharma/Biotech
Dublin
R&D Engineer
Galway
Project Manager
Galway
Manufacturing Technician
Clare
Environmental Health & Safety (EHS)
Longford
Senior Quality Engineer
Dublin
Graduate Occupational Hygiene Consultant
Kildare
Quality Engineer
Galway
Senior Principal Design and Development
Galway
Quality Specialist
Clare
Senior Quality Systems Engineer
Galway
Principal R&D Engineer
Galway
R&D Manager
Dublin
Engineering Business Manager
Dublin
Director of Regulatory Affairs
Galway
Project Manager - New Product Introducti
Dublin
Quality Systems Manager
Dublin
Quality Engineer
Galway
Quality Engineer - Supplier
Galway
Biomedical Engineer
Dublin
Senior Operational Readiness Associate
Dublin
Design Assurance Engineer
Galway
Part time Opportunity-Senior QA Speciali
Dublin
Advanced Technologies R&D Manager
Clare
Senior Quality Engineer
Galway
Key Account Manager - Retail UK National
South East
Process Engineer
Leitrim
Director of R&D
Limerick
Process Chemist
Limerick
Project Manager (hybrid)
Dublin
R&D Manager
Athlone
Project Engineer
Roscommon
Senior Quality Assurance Specialist
Cork
Sr Principal R&D Engineer
Galway
Process Engineer
Galway
Quality Engineer
Athlone
Principal Design and Development Enginee
Galway
Senior QC Associate (Bioassay)
Dublin
Application Software Engineer
Galway
Quality Engineer
Wexford
Biomedical Engineer
Dublin
Senior Research & Development Engine
Limerick
R&D Senior Program Manager
Galway
Senior Manufacturing Engineer
Galway
R&D Engineer
Galway
Senior Equipment Design Engineer
Dublin
Principal Software Engineer
Athlone
Operations Manager
Galway
Senior R&D Engineer
Galway
Senior Specialist MS&T
Dublin
Senior R&D Engineer
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Commercial Solutions Manager (Medical De
Dublin
Validation Engineer
Athlone
Quality Manager
Dublin
Business Development Manager
Republic of Ireland
Calibration Technician
Republic of Ireland
Principal Device Engineer
Dublin
Project Manager
Kildare
Senior Design Engineer
Dublin
Senior Maintenance Technician
Kilkenny
R&D Director
Galway
Product Development Manager
Galway
R&D Engineer
Galway
QA Engineer
Leitrim
Health & Safety Specialist
Dublin
Senior Quality Engineer
Leitrim
Quality Assurance Specialist
Carlow
Quality Assurance Specialist (Logistics)
Dublin
Senior Quality Engineer
Dublin
R&D Manager
Galway
Senior Quality Engineer
Dublin
Principal Quality Engineer
Galway
Senior Quality Assurance Associate
Dublin
Senior Equipment Design Engineer
Dublin
Strategic Automation Lead
Waterford
Quality Specialist
Tipperary
R&D Manager
Connaught
Senior R&D Engineer
Galway
R&D Manager
Galway
Senior Quality Engineer
Dublin
R&D Engineer
Dublin
Senior R&D Engineer
Galway
Senior Manufacturing Engineer
Galway City
Lab Manager
Down
Senior Electronics Engineer
Limerick
R&D Engineer
Clare
Warehouse Operator
Dublin
Quality Assurance Specialist (hybrid)
Dublin
R&D Manager
Connaught
Senior Electrical Engineer
Galway
R&D Director
Galway
Senior Process Development Engineer
Dublin
Senior Quality Engineer
Dublin
Continuous Improvement Coach
Limerick
Product Development Engineer
Dublin
Senior Product Development Engineer
Galway
Quality Specialist
Clare
Senior Quality Assurance Technical Suppo
Dublin
Laboratory Systems Specialist
Meath
Senior Equipment Design Engineer
Dublin
Senior QA Specialist
Dublin
QA Manager
Canada
Staff R&D Engineer
Limerick
Senior Engineering Manager
Galway
Product Development Engineer II
Athlone
Senior R&D Engineer
Galway
Senior Manufacting Engineer
Republic of Ireland
Senior NPI Engineer - Hybrid
Dublin
Senior R&D Engineer-New Product Deve
Westmeath
Director of Regulatory Affairs
Galway
Quality Assurance Engineer
Longford
R&D Manager
Connaught
Quality Assurance Team Lead
Cork
Director Engineering & Supply Chain
Galway
R&D Director
Galway
Sr Project Manager - Syringe Fill Engine
Dublin
Microbiology Manager
Dublin
Senior Project Engineer
Cavan
CTO
Galway
Principal Engineer
Dublin
Senior QC Bioassay Associate
Dublin
Injection Moulding Engineer
Athlone
Validation Engineer
Republic of Ireland
Quality Engineer
Galway
Senior Quality Engineer
Galway
Design Assurance Engineer
Galway
R&D Manager
Connaught
Associate Quality Specialist
Tipperary
Design Assurance Manager
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Senior Electronic Engineer - Regulated M
Galway
Product Development Technician II
Galway
Quality Manager
Dublin
Senior Microbiologist
Dublin
R&D Manager
Galway
Principal Reliability Engineer
Galway
Production Operator
Meath
Quality Manager
Galway
QA Operations Specialist
Dublin
Product Specialist - Imaging/ Radiograph
Dublin
Quality Technician
Dublin
Senior QA Specialist
Dublin
Project Manager
Kildare
Responsible Person (RP)
Republic of Ireland
Inside Sales Representative (IVD Divisio
Kildare
Design Assurance Program Manager
Galway
Manufacturing Technician
Clare
Principal Engineer
Dublin
Senior R&D Engineer
Galway
Mechanical Technician
Carlow
Quality Manager - NPI
Dublin
R&D Lifecycle Manager
Connaught
Senior R&D Engineer
Dublin
R&D Engineer
Galway
Senior Product Development Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Product Specialist (Critical Care &
Dublin
Process Development Engineer
Galway
Principal R&D Engineer
Galway
R&D Engineer
Galway
Engineering Shift Technician
Dublin
Technical Life Cycle & Engineering M
Galway
R&D Manager
Athlone
Senior Regulatory Specialist
Cork
(Senior) Manufacturing Engineers - Globa
Limerick
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