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
Wexford
Senior R&D Engineer
Galway
R&D Chemist
Wexford
Commisioning and Qualification Engineer
Cork
Senior Manufacting Engineer
Republic of Ireland
MS&T Associate Director
Dublin
Sourcing Specialist
Tipperary
Quality Specialist
Tipperary
Electronic Engineer
Dublin
Manufacturing Technician
Clare
Senior Quality Engineer
Leitrim
NPI Process Engineer
Carlow
Notified Body Product Assessor -Active D
Canada
Product Development Engineer
Dublin
Quality Engineer
Athlone
Project Engineer
Cork
Head of R&D
Galway
Clinical Research Associate
Cork
R&D Director
Galway
Shift Technician (Injection Moulding)
Kildare
Principal Engineer
Dublin
Clinical Project Manager
Cork
Principal R&D Engineer
Galway
Biostatistician
Dublin City Centre
Product Development Technician II
Galway
Senior Equipment Design Engineer
Dublin
Analytical Scientist
Meath
Senior Operations Engineer
Galway
Senior Quality Engineer
Dublin
Clinical Research Associate
Cork
Senior Regulatory Affairs
Galway
Senior Product Development Engineer
Galway
Design Assurance Engineer
Clare
Electronic Design Engineer
Galway
Process Chemist
Limerick
Injection Molding Engineer
North Leinster
Senior Recruitment Consultant
Republic of Ireland
Lead Chemistry Analyst
Cork
Project Manager - R&D
Galway
Quality Engineer
Galway
Embedded Software Engineer
Dublin
Senior Quality Systems Engineer
Galway
Regulatory Affairs Maanger
Galway
R&D Manager
Galway
Process Engineer
Carlow
R&D Engineer
Galway
Manufacturing Engineer
Galway
Senior Validation Engineer
Dublin
Quality Director
Galway
Principal Reliability Engineer
Galway
Quality Engineer
Galway
NPI Process Engineer
Carlow
Validation & Verification Engineer
Dublin
Maintenance & Reliability Technician
Limerick
Process Simulation Technical Engineer
Carlow
Product Development Engineer
Dublin
Manufacturing Engineer
Galway
Software Design Assurance Engineer
Dublin
Product Development Engineer
Galway
Product Development Manager
Galway
Product Development Engineer
Dublin
R&D Manager
Dublin
Project Manager - R&D
Galway
Senior Associate Quality Control
Dublin
Electronic Engineer
Dublin
Project Manager - R&D
Galway
Production Operator
Meath
R&D Director
Galway
Electrical Project Engineer
Cork
Principal Process Equipment Engineer
Dublin South
Senior Regulatroy Affairs Specialsit
Galway
Quality Engineer
Wexford
Design Assurance Engineer
Clare
Manufacturing Project Engineer
Sligo
Associate QA Specialist (Shift)
Carlow
Quality Manager - Medical Devices
Limerick City
Senior R&D Engineer-New Product Deve
Westmeath
Quality Manager
Dublin
Project Engineer
Cork
Senior R&D Engineer
Galway
Quality and Regulatroy Manager
Galway
Quality Specialist
Clare
Manufacturing Engineer
Cork
Quality Systems Specialist
Tipperary
R&D Lifecycle Manager
Connaught
Senior Tech Transfer Specialist
Meath
Project Engineer
Cork
Product Development Engineer II
Athlone
R&D Engineer
Clare
Senior QA Specialist (hybrid)
Tipperary
Responsible Person (RP)
Republic of Ireland
Senior Research and Development Engineer
Galway
DeltaV Lead Automation Engineer
Tipperary
Principal Engineer
Dublin
Documentation Specialist
Louth
Senior Human Factors Engineer
Dublin
Biomedical Engineer
Dublin
Biomedical Engineer
Dublin
Quality Engineer
Athlone
QA Engineer
Leitrim
Quality Specialist & Deputy RP
Limerick
Manufacturing Engineer
Cork
R&D Engineer
Galway
Quality Technician
Dublin
Senior Equipment Design Engineer
Dublin
Application Software Engineer
Galway
Validation Specialist - 50/50 remote
Carlow
R&D Manager
Connaught
Documentation Specialist
Louth
Project Engineer
Limerick
Senior Regulatory Affairs Specialist
Athlone
R&D Engineer
Galway
Maintenance CMMS Engineer
Tipperary
R&D Technician II
Galway
Project Engineer - Senior
Cavan
Senior Regulatory Affairs Specialist
Athlone
R&D Engineer
Galway
Quality Control Technician
Carlow
CTO
Dublin
R&D Senior Program Manager
Galway
Principal R&D Engineer
Dublin
Account Manager (Chemicals) - Dublin
Dublin
Senior Equipment Engineer
Dublin
Project Manager
Kildare
Injection Moulding Engineer
Athlone
R&D Manager
Galway
Injection Moulding Engineer
Athlone
Senior Design Engineer
Dublin
Principal Research and Development Engin
Galway
R&D Manager
Galway
Engineering Support Specialist
Louth
Senior Electrical Engineer
Galway
Senior R&D Engineer
Galway
Design Quality Engineer
Galway
R&D Engineer
Galway
Quality Engineer
Athlone
CTO
Galway
Mechanical Technician
Carlow
Technology Transfer Specialist
Meath
Project Manager
Kildare
Senior R&D Engineer
Galway
Mechanical Technician - 2 Cycle
Carlow
Manufacturing Technician
Clare
R&D Engineer
Dublin
Project Manager - Tech Transfer
Louth
R&D Manager
Connaught
Graduate Manufacturing Technician
Kilkenny
R&D Engineer
Dublin
R&D Manager
Athlone
Senior Research & Development Engine
Limerick
Senior Electronic Engineer - Regulated M
Galway
Senior Recruitment Consultant
Republic of Ireland
Technical Transfer Specialist
Cork
Senior Validation Engineer
Carlow
Senior R&D Manager/Director
Dublin
Principal Heart Valves Engineer
Galway
Regulatory Associate
Cork
Senior Design Engineer
Dublin
Senior QC Associate
Dublin
Senior Technical Transfer Engineer - Hyb
Carlow
Senior QC Associate
Dublin
Senior Operations Engineer
Galway
Microbiology Manager
Dublin
R&D Technician
Galway
R&D Engineer
Galway
QC Bioanalytical Analyst
Dublin North
R&D Engineer
Galway
R&D Director
Galway
Senior Quality Engineer
Dublin
Senior Quality Engineer
Leitrim
Clinical Trial Quality Representative
Cork
Senior R&D Engineer
Clare
Principal R&D Engineer
Dublin
Principal Scientist/Engineer Medical Dev
Dublin
Facilities Engineer
Carlow
Quality Specialist (Shift)
Dublin
Project/Process Engineer - Purification
Cork
Technical Specialist (Hybrid)
Cork
DeltaV Technical Coordinator - Hybrid
Tipperary
Senior Design Assurance Engineer
Galway
Electronic Engineer
Dublin
Manufacturing Engineer
Galway
Reliability Engineering Consultant - Rem
Republic of Ireland
R&D Manager
Connaught
Principal Instrumentation & Calibrat
Limerick
Production Manager
Dublin
QC Bioanalytical Analyst
Dublin North
Commerical Director
Outside EU
Team Leader - Lab Services
Dublin
Quality Assurance Engineer
Longford
Injection Molding Engineer
North Leinster
Senior Design Assurance Engineer
Galway
Value Stream Team Leader / Production Su
Wexford
Senior R&D Engineer - Sustaining
Galway
EHS Systems Specialist
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
R&D Manager
Galway
Senior Polymer Development Engineer
Galway
R&D Manager
Connaught
QA Manager
Canada
Project Engineer
Clare
Senior Equipment Design Engineer
Dublin
R&D Engineer
Galway
Senior QC Microbiology (24/7 Shift)
Dublin
Senior Design Engineer
Dublin
Senior Electronic Engineer
Dublin
QC Laboratory Technician (shift)
Carlow
Process Engineer
Galway
Principal Process Development Engineer
Dublin
Regulatory Affairs Associate
Cork
Quality Engineer
Galway
Associate Director - Global Core Labelin
Cork
Utilities Engineer - Black Utilities
Roscommon
Utilities Engineer
Dublin
R&D Manager
Athlone
Senior Quality Engineer-Remote
Republic of Ireland
Principal R&D Engineer
Galway
R&D Director
Galway
Senior R&D Manager
Athlone
R&D Technician II
Galway
Injection Molding Engineer
North Leinster
R&D Engineer
Galway
Calibration Technician
Republic of Ireland
Senior R&D Engineer
Galway
Quality Technician
Dublin
Quality Technician
Dublin
QA Manager
Canada
Advanced Technologies R&D Manager
Clare
MS&T Associate Director
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Senior Human Factors Engineer
Dublin
Advanced Technologies Manager
Galway
Account Manager UK and Ireland
Republic of Ireland
Quality Operations Manager
Dublin
Operational Excellence Specialist
Cork
Senior R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Production & Logistics Planner
Galway
R&D Manager
Galway
Senior Project Engineer
Cavan
VP of Operations
Dublin
Senior R&D Project Manager
Galway
Quality Engineer
Galway
Manufacturing Technician
Clare
R&D Engineer
Galway
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