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 Technician
Dublin
R&D Engineer
Galway
QA Manager
Canada
Learning Systems Lead
Limerick
Principal R&D Engineer
Galway
Product Development Engineer
Galway
Clinical Sales Specialist (Histology)
Dublin
Project Manager - New Product Introducti
Dublin
Lead MSAT Validation Consultant
Republic of Ireland
Industrial Designer
Galway
Senior Regulatory Affairs Manager
Galway
R&D Manager
Galway
Quality Manager
Galway
Senior Process Engineer - Packaging
Dublin
Senior Product Development Engineer
Galway
R&D Engineer
Galway
CQV Engineer
Roscommon
Senior Quality Assurance Engineer
Galway
R&D Technician II
Galway
Senior Process Development Engineer
Dublin
Instrumentation Engineer
Meath
Documentation Specialist
Louth
Senior Quality Control Associate
Dublin South
Manufacturing Technician
Clare
Design Assurance Program Manager
Galway
EHSS Specialist
Athlone
Senior QC Specialist
Dublin
Senior R&D Engineer
Galway
Territory Manager (Endoscopy)
Dublin
R&D Manager
Connaught
Lead Mechanical Design Engineer
Limerick
Equipment Engineer Intermediate
Dublin
R&D Director
Galway
R&D Director
Galway
Senior Clinical Data Analyst
Dublin
R&D Engineer
Dublin
Business Development Manager
Republic of Ireland
Senior Electrical Engineer
Galway
Clinical Trial Protocol Specialist
Galway
A.I Specialist
Clare
Continuous Improvement Specialist
Dublin
Quality Engineer
Athlone
Senior QC Associate - Equipment & I
Dublin
Senior R&D Engineer
Dublin
Senior Quality Engineer
Leitrim
Environmental Health & Safety (EHS)
Longford
Senior Design Assurance Engineer
Galway
Biomedical Engineer
Dublin
CTO
Dublin
Senior Project Engineer
Cavan
Senior Equipment Design Engineer
Dublin
Quality Manager
Galway
Analytical Chemist
Tipperary
R&D Manager
Galway
R&D Manager
Galway
Business Development Manager (Hospitals)
Cork
Injection Moulding Engineer
Athlone
Senior Quality Engineer
Dublin
Senior Electronics Engineer
Limerick
Quality Engineer - Supplier
Galway
Electrical Condition Monitoring Technici
Limerick
R&D Engineer
Clare
Senior Associate Quality Control
Dublin
Clinical Trial Protocol Specialist
Galway
Regulatory Affairs Manager- Remote
Republic of Ireland
R&D Engineer
Galway
R&D Manager
Galway
Documentation Specialist
Louth
Senior Quality Engineer
Leitrim
Clinical Trial Protocol Specialist
Galway
Quality Engineer
Wexford
Product Specialist (Critical Care &
Dublin
Senior Clinical Data Analyst
Dublin
Senior QA Associate (shift)
Dublin
Senior R&D Engineer
Dublin
Senior NPI Engineer - Hybrid
Dublin
Senior Clinical Data Analyst
Dublin
Documentation Specialist
Louth
Senior Quality Assurance Specialist (hyb
Dublin
Product Development Engineer II
Athlone
R&D Manager
Athlone
Quality Manager - Medical Devices
Limerick City
Business Resilience Specialist
Dublin
Senior R&D Manager
Athlone
Injection Molding Engineer
Mayo
Senior Quality Engineer
Dublin
Principal Reliability Engineer
Galway
Technical Life Cycle & Engineering M
Galway
Senior Quality Engineer
Galway
Senior Clinical Engagement Project Manag
Dublin
Manufacturing Engineer
Galway
Senior Regulatory Affairs Specialist
Dublin
R&D Technician
Galway
Bid Response Strategy Manager
Dublin
Senior Operational Readiness Associate
Dublin
Injection Moulding Engineer
Leitrim
Quality Assurance Specialist
Waterford
Senior R&D Engineer
Galway
Quality Manager
Dublin
Senior Quality Engineer
Galway
Senior Commissioning & Qualification
Roscommon
Design Assurance Engineer
Galway
CTO
Galway
Quality Assurance Senior Specialist
Louth
Senior Quality Engineer
Dublin
Process Chemist
Limerick
Senior Electronic Engineer
Dublin
Embedded Software Engineer
Dublin
Quality Control Analyst (Cell Culture)
Carlow
Senior Supply Chain Project Manager
Dublin
Black Utilities Engineer
Westmeath
R&D Manager
Connaught
R&D Program Manager
Dublin
Principal Device Engineer
Dublin
EHS Specialist II
Limerick
Business Development Manager (Hospitals)
Cork
QC Specialist
Clare
Quality Engineer
Athlone
Senior Design Assurance Engineer
Galway
Inside Sales Support & Sourcing Spec
Dublin
R&D Engineer
Dublin
Senior Electronic Engineer
Dublin
Bioinformatician
Dublin
Senior Supplier Engagement Manager
Dublin
Principal Engineer
Dublin
Senior Production Manager
Cork
Shift Technician (Injection Moulding)
Kildare
Quality Manager
Galway
Quality Technician
Galway
R&D Manager
Athlone
Senior Regulatory Affairs Specialist
Athlone
Senior Equipment Design Engineer
Dublin
Senior Sterile Drug Product MSAT Consult
Republic of Ireland
Senior Scientific Officer
Dublin
R&D Engineer
Galway
Sales/Customer Service Administrator
Clonmel
Staff R&D Engineer
Limerick
Director of R&D
Clare
Senior R&D Engineer-New Product Deve
Westmeath
Quality Assurance Specialist (hybrid)
Dublin
Design Quality Engineer
Galway
Senior Quality Assurance Engineer
Galway
R&D Senior Program Manager
Galway
Senior Regulatory Affairs Specialist
Clare
Senior Quality Engineer
Dublin
Process Scientist MSAT
Louth
Senior QC Analyst
Republic of Ireland
Quality Manager
Galway
Regulatory Affairs Specialist
Cork
Environmental Health & Safety (EHS)
Longford
Director of R&D
Limerick
Senior Maintenance Technician
Roscommon
Quality Assurance Team Lead
Cork
R&D Engineer
Galway
Senior Quality Assurance Specialist
Cork
Senior R&D Engineer
Galway
Regulatory Affairs Maanger
Galway
Senior Maintenance Technician
Kilkenny
Process Engineer - Sterile Drug Product
Waterford
Senior R&D Manager - Lifecycle Manag
Galway
R&D Director
Galway
Senior Technology Transfer Specialist
Dublin
Validation Engineer Intermediate
Dublin
Senior Regulatory Affairs
Galway
Quality Specialist
Clare
Senior Project Design Engineer
Limerick
Senior Equipment Design Engineer
Dublin
Senior QC Associate - NPI
Dublin
Manufacturing Specialist - Aseptic Proce
Dublin
LIMS Specialist
Tipperary
Senior Regulatory Affairs Specialist
Athlone
Quality Assurance Engineer
Longford
Microbiology Quality Supervisor
Louth
A.I Specialist
Clare
Senior Research and Development Engineer
Galway
Quality Engineer - Supplier
Galway
Quality Assurance Associate
Cork
EHSS Specialist (Construction & Comm
Athlone
Senior R&D Engineer
Dublin
Tech Transfer Lead
Dublin
Senior Regulatory Specialist
Cork
Senior Project Engineer
Cavan
R&D Engineer
Galway
Senior R&D Engineer
Galway
Quality Manager
Galway
Biomedical Engineer
Dublin
Senior Quality Engineer
Leitrim
R&D Manager
Connaught
Engineering Business Manager
Dublin
EHS Specialist II
Limerick
Senior R&D Engineer
Dublin
R&D Director
Galway
Project Manager (hybrid)
Dublin
Senior Manufacturing Engineer
Galway
Senior Quality Engineer
Dublin
Senior Process Engineer
Dublin
Quality Assurance Specialist
Dublin
Principal Engineer
Dublin
Principal Design and Development Enginee
Galway
R&D Manager
Connaught
R&D Engineer
Galway
Production Operator
Meath
R&D Engineer
Galway
Senior Operations Engineer
Galway
Key Account Manager - Retail UK National
South East
QA Deviations Specialist
Dublin
Injection Moulding Engineer
Athlone
Senior Manufacting Engineer
Republic of Ireland
Senior Client Side Design Manager
Westmeath
Director of Regulatory Affairs
Galway
R&D Manager
Galway
Quality Specialist
Tipperary
Process Engineer
Galway
Proposal Manager
Dublin
Senior Clinical Data Analyst
Dublin
Project Manager
Kildare
Senior Equipment Design Engineer
Dublin
Director of R&D
Galway
Director of Regulatory Affairs
Galway
Senior Engineering Manager
Limerick
Responsible Person (RP)
Republic of Ireland
Senior Quality Assurance Technical Suppo
Dublin
R&D Engineer
Galway
Calibration Technician
Republic of Ireland
Principal Software Engineer
Athlone
Senior Engineering Manager
Galway
Product Development Technician II
Galway
Quality Assurance Specialist
Carlow
Senior Product Development Engineer
Galway
R&D Lifecycle Manager
Connaught
Project Engineer
Clare
R&D Engineer
Galway
Manufacturing Technician
Clare
Senior QC Microbiology
Dublin
QA Engineer
Leitrim
Asbestos Analyst
Down
Principal R&D Engineer
Dublin
Senior R&D Engineer
Galway
Project Manager
Kildare
Design Assurance Manager
Galway
Project Manager
Galway
Principal Quality Engineer
Galway
Senior Operations Engineer
Galway
R&D Manager
Dublin
Product Development Technician II
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