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 Manager
Canada
Senior Operations Engineer
Galway
R&D Manager
Galway
Validation & Verification Engineer
Dublin
Senior Manufacturing Engineer
Galway City
R&D Director
Galway
Senior Equipment Design Engineer
Dublin
Senior Process Development Engineer
Galway
Quality Engineer
Athlone
Business Development Manager
Republic of Ireland
Principal Engineer
Dublin
CTO
Galway
Senior Regulatory Affairs Specialist
Athlone
Senior Quality Engineer
Dublin
R&D Engineer
Dublin
R&D Manager
Connaught
Product Development Engineer II
Athlone
Quality Manager
Galway
Senior Process Engineer - Packaging
Dublin
Lead MSAT Validation Consultant
Republic of Ireland
R&D Lifecycle Manager
Connaught
Senior QA Associate (shift)
Dublin
Asbestos Analyst
Down
Technical Transfer Specialist - Remote
Republic of Ireland
Senior R&D Engineer
Dublin
Product Development Engineer
Galway
Senior Regulatory Affairs Manager
Galway
Process Chemist
Limerick
Product Development Engineer
Dublin
Senior Research & Development Engine
Limerick
Engineering Shift Technician
Dublin
Senior R&D Engineer
Galway
Design Assurance Engineer
Galway
R&D Director
Galway
Senior Research and Development Engineer
Galway
Principal Reliability Engineer
Galway
Documentation Specialist
Louth
R&D Engineer
Galway
R&D Manager
Galway
Senior Quality Systems Engineer
Galway
Quality Engineer - Supplier
Galway
Senior Electronic Engineer
Dublin
Senior R&D Engineer II
Galway
Director of R&D
Limerick
Environmental Health & Safety (EHS)
Longford
Design Assurance Manager
Galway
EHS Specialist II
Limerick
R&D Technician II
Galway
R&D Engineer
Galway
Senior R&D Engineer
Galway
Senior Maintenance Technician
Kilkenny
Warehouse Operator
Dublin
Injection Moulding Engineer
Athlone
Senior Project Manager
Meath
Principal R&D Engineer
Galway
Senior Manufacting Engineer
Republic of Ireland
Product Development Manager
Galway
Senior Regulatory Affairs Specialist
Dublin
Senior Electronics Engineer
Limerick
Manufacturing Technician
Clare
Senior Quality Assurance Associate
Dublin
R&D Engineer
Dublin
Manufacturing Specialist (Investigation
Dublin
Senior R&D Manager
Athlone
Manufacturing Process Specialist
Dublin
Senior Quality Engineer
Leitrim
Senior Project Engineer
Cork
Senior R&D Engineer
Dublin
R&D Manager
Athlone
Part time Opportunity-Senior QA Speciali
Dublin
Sr Electrical Engineer
Galway
Manufacturing Engineer
Galway
Design Assurance Engineer
Galway
R&D Director
Galway
Laboratory Systems Specialist
Meath
Marketing Manager
Galway
Environmental Health & Safety (EHS)
Longford
Senior Quality Engineer
Dublin
Senior Regulatory Specialist
Cork
Quality Manager
Galway
Quality Assurance Senior Specialist
Louth
Senior Manufacturing Engineer
Galway
R&D Engineer
Galway
R&D Engineer
Galway
Advanced Technologies Manager
Galway
R&D Engineer
Galway
Documentation Specialist
Louth
Senior Principal Design and Development
Galway
R&D Manager
Galway
R&D Engineer
Galway
Reg Affairs Specialist
Connaught
Senior Process Engineer - DP or DS
Dublin
Product Specialist - Orthopaedic Divisio
Dublin
Quality Assurance Specialist (shift)
Carlow
Senior R&D Manager - Lifecycle Manag
Galway
Project Manager
Kildare
Tech Transfer Lead - Sterile Drug Produc
Dublin
Quality Control Analyst (Cell Culture)
Carlow
Technical Life Cycle & Engineering M
Galway
Quality Specialist
Clare
R&D Manager
Connaught
Senior R&D Manager - Lifecycle Manag
Galway
Production Manager
Dublin
Senior Quality Engineer
Leitrim
Project Manager
Galway
Embedded Software Engineer
Dublin
Senior R&D Engineer
Galway
Quality Specialist
Clare
Senior Commissioning & Qualification
Roscommon
Quality Specialist
Clare
Product Development Manager
Galway
Senior R&D Engineer
Clare
Operations Engineer
Galway
Biomedical Engineer
Dublin
Calibration Technician
Republic of Ireland
Senior Research and Development Engineer
Galway
R&D Manager
Athlone
Graduate Occupational Hygiene Consultant
Kildare
Quality Manager
Galway
Quality Specialist
Tipperary
Principal Quality Engineer
Galway
Senior QA Specialist
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Senior Clinical Data Analyst
Dublin
Senior Regulatory Affairs Specialist
Clare
Quality Manager
Dublin
Senior Design Engineer
Dublin
Senior Product Development Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
R&D Engineer
Galway
Territory Manager (Endoscopy)
Dublin
Senior Audit & Compliance Specialist
Galway
Director of R&D
Galway
Senior Reg Affairs Specialist - Post Mar
Galway
Validation Engineer
Carlow
Director Engineering & Supply Chain
Galway
Senior Equipment Design Engineer
Dublin
Product Development Engineer
Galway
Sr Principal R&D Engineer
Galway
Product Development Engineer II
Athlone
Senior R&D Engineer
Dublin
Warehouse Operator
Dublin
Senior QC Microbiology
Dublin
Senior R&D Engineer
Galway
Senior Product Development Engineer
Galway
Senior R&D Engineer
Galway
Responsible Person (RP)
Republic of Ireland
Validation Engineer
Athlone
Regulatory Affairs Manager - Senior
Galway
LIMS Specialist
Tipperary
Project Manager (hybrid)
Dublin
Product Development Technician II
Galway
R&D Manager
Dublin
CTO
Dublin
Quality Engineer
Galway
Senior Regulatory Specialist
Cork
Quality Engineer - Supplier
Galway
Senior Design Assurance Engineer
Galway
R&D Engineer
Clare
Regulatory Affairs Specialist
Cork
Project Engineer
Roscommon
Senior Design Assurance Engineer
Galway
Senior QC Specialist - Equipment & I
Dublin
Administrative Assistant
Tipperary
Quality Assurance Engineer
Longford
Project Manager
Kildare
Senior QC Microbiology
Dublin
Quality Assurance Team Lead
Cork
R&D Manager
Galway
QA Engineer
Leitrim
Senior Quality Engineer
Dublin
Senior Manufacturing Engineer
Cork
Documentation Specialist
Louth
Senior R&D Engineer
Galway
Senior Process Development Engineer
Dublin
Quality Assurance Associate
Cork
Application Software Engineer
Galway
Principal R&D Engineer
Galway
Senior R&D Engineer
Galway
R&D Manager
Connaught
Electrical Condition Monitoring Technici
Limerick
Tech Transfer Lead
Dublin
Staff Systems Engineer
Limerick
R&D Manager
Connaught
Senior Maintenance Technician
Roscommon
Senior Project Engineer
Cavan
Senior Regulatroy Affairs Specialsit
Galway
Design Quality Engineer
Galway
Senior Design Engineer
Dublin
Sales/Customer Service Administrator
Clonmel
Senior Maintenance Technician
Kilkenny
Manufacturing Technician
Clare
Quality Manager
Galway
R&D Manager
Galway
Senior Engineering Manager
Galway
Principal R&D Engineer
Dublin
R&D Engineer
Galway
Quality Assurance Specialist (Logistics)
Dublin
Senior Equipment Design Engineer
Dublin
Strategic Automation Lead
Waterford
Quality Assurance Specialist (shift)
Carlow
Senior Quality Engineer
Galway
Quality Assurance Specialist (hybrid)
Dublin
Quality Manager - Medical Devices
Limerick City
Senior Operations Engineer
Galway
Quality Engineer
Wexford
Quality Manager
Dublin
Quality Engineer
Galway
Senior Engineering Manager
Limerick
Biomedical Engineer
Dublin
R&D Engineer
Galway
Staff R&D Engineer
Limerick
Senior Regulatory Affairs Specialist
Westmeath
CAPEX API Project Manager
Tipperary
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