
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.
![]() Google Chrome |
![]() Internet Explorer |
![]() Mozilla Firefox |
![]() 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
Senior Validation Engineer
Carlow
Carlow
R&D Manager
Athlone
Athlone
Principal R&D Engineer
Dublin
Dublin
Quality Engineer
Athlone
Athlone
Microbiology Manager
Dublin
Dublin
Quality Engineer
Athlone
Athlone
Principal Engineer
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
R&D Manager
Galway
Galway
Quality Engineer
Galway
Galway
Senior Validation Engineer
Carlow
Carlow
Principal Software Engineer
Athlone
Athlone
Maintenance Technician
Kilkenny
Kilkenny
Senior Quality Engineer
Dublin
Dublin
Project Engineer
Clare
Clare
Senior Quality Engineer
Galway
Galway
Quality Manager
Dublin
Dublin
Engineering Shift Technician
Dublin
Dublin
Senior R&D Engineer
Clare
Clare
Production Operator
Meath
Meath
R&D Director
Galway
Galway
Design Assurance Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
Senior Procurement Associate
Limerick
Limerick
Senior R&D Engineer
Dublin
Dublin
Quality Specialist
Dublin
Dublin
Chief Medical Officer
Dublin
Dublin
Quality Engineer
Galway
Galway
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Product Development Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Quality Technician
Dublin
Dublin
R&D Manager
Connaught
Connaught
Senior Electronics Engineer
Dublin
Dublin
Senior Maintenance Technician
Kilkenny
Kilkenny
CTO
Galway
Galway
Senior Quality Engineer-Remote
Republic of Ireland
Republic of Ireland
Product Development Manager
Galway
Galway
Senior R&D Engineer
Clare
Clare
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
Qualified Person (Hybrid)
Tipperary
Tipperary
Electronic Engineering
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Maintenance CMMS Engineer
Tipperary
Tipperary
Senior R&D Project Manager
Galway
Galway
DeltaV Lead Automation Engineer
Tipperary
Tipperary
Quality Engineer
Galway
Galway
Mechanical Technician
Carlow
Carlow
Field Service Engineer (Chromatography e
Westmeath
Westmeath
Mechanical Engineer
Tipperary
Tipperary
Quality Engineer
Athlone
Athlone
R&D Engineer
Galway
Galway
Senior Electronics Engineer
Limerick
Limerick
Electronic Engineer
Dublin
Dublin
Embedded Software Engineer
Dublin
Dublin
R&D Lifecycle Manager
Connaught
Connaught
MS&T Bioprocess Engineer
Meath
Meath
Strategic Automation Lead
Waterford
Waterford
Senior Electrical Engineer
Galway
Galway
Product Development Engineer
Galway
Galway
Lead Project Engineer
Carlow
Carlow
Project Manager - R&D
Galway
Galway
R&D Manager
Dublin
Dublin
Maintenance Technician
Kilkenny
Kilkenny
Compliance Specialist
Carlow
Carlow
Process Safety Specialist
Tipperary
Tipperary
Senior R&D Engineer
Galway
Galway
R&D Manager
Connaught
Connaught
Quality Engineer
Galway
Galway
Engineering Business Manager
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
Production Operator
Carlow
Carlow
QC Laboratory Technician
Carlow
Carlow
Injection Molding Engineer
North Leinster
North Leinster
Senior Associate QC
Dublin
Dublin
Investigation Lead
Dublin
Dublin
Principal Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
CAPA Specialist
Cavan
Cavan
Program Manager
Galway
Galway
R&D Project Manager
Galway
Galway
Project Engineer
Cork
Cork
R&D Manager
Galway
Galway
Senior Validation Engineer
Dublin
Dublin
QA Specialist (Shift days)
Dublin
Dublin
Senior Quality Engineer
Leitrim
Leitrim
Product Development Engineer
Dublin
Dublin
Process Support Specialist
Carlow
Carlow
Injection Molding Engineer
North Leinster
North Leinster
Quality Control Technician
Carlow
Carlow
Design Assurance Engineer
Galway
Galway
Senior R&D Engineer
Clare
Clare
Senior Equipment Engineer
Dublin
Dublin
Facilities Engineer
Carlow
Carlow
QA Manager
Canada
Canada
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
R&D Engineer
Galway
Galway
Manufacturing Technician
Clare
Clare
Process Engineer
Carlow
Carlow
Accreditation Manager
Republic of Ireland
Republic of Ireland
Process Engineer
Cork
Cork
Program Manager
Galway
Galway
Design Assurance Engineer
Galway
Galway
Electronic Engineer
Dublin
Dublin
R&D Engineer
Galway
Galway
Microbiologist
Cork
Cork
Project Engineer
Cork
Cork
Product Development Engineer
Dublin
Dublin
Technical Administrator
Tipperary
Tipperary
QA Engineer
Leitrim
Leitrim
Senior Electronic Engineer
Dublin
Dublin
Maintenance Technician
Carlow
Carlow
Graduate Manufacturing Technician
Kilkenny
Kilkenny
Design Assurance Engineer
Galway
Galway
Electronic Engineer
Dublin
Dublin
Injection Moulding Engineer
Athlone
Athlone
Project Manager - R&D
Galway
Galway
R&D Engineer
Galway
Galway
Project Manager - R&D
Galway
Galway
Staff Systems Engineer
Limerick
Limerick
Quality Engineer
Galway
Galway
Product Development Engineer II
Athlone
Athlone
Staff R&D Engineer
Limerick
Limerick
Program Manager
Galway
Galway
Material Handler
Carlow
Carlow
Senior Quality Engineer
Leitrim
Leitrim
Senior Process Engineer
Dublin
Dublin
Principal R&D Engineer
Galway
Galway
R&D Engineer
Dublin
Dublin
Senior QC Associate - Cell Culture
Dublin South
Dublin South
Product Development Engineer
Galway
Galway
Injection Molding Engineer
North Leinster
North Leinster
Reg Affairs Specialist
Clare
Clare
Manufacturing Engineer
Galway
Galway
Senior Quality Engineer
Leitrim
Leitrim
R&D Director
Galway
Galway
R&D Engineer
Galway
Galway
Product Development Engineer
Dublin
Dublin
R&D Manager
Galway
Galway
Project Engineer
Cork
Cork
Quality Engineer
Wexford
Wexford
R&D Engineer
Galway
Galway
R&D Technician II
Galway
Galway
R&D Engineer
Galway
Galway
Project Scheduler
Louth
Louth
Senior R&D Engineer
Galway
Galway
R&D Engineer
Dublin
Dublin
Biostatistician
Dublin City Centre
Dublin City Centre
Quality Manager - Medical Devices
Limerick City
Limerick City
Quality Technician
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Maintenance Reliability Engineer
Tipperary
Tipperary
Responsible Person (RP)
Republic of Ireland
Republic of Ireland
Quality Specialist
Dublin
Dublin
Lead Manufacturing Technician
Kilkenny
Kilkenny
MS&T Associate Director
Dublin
Dublin
VP of Operations
Dublin
Dublin
Account Manager UK and Ireland
Republic of Ireland
Republic of Ireland
Manufacturing Technician
Clare
Clare
QA Manager
Canada
Canada
Production Operator
Meath
Meath
Senior R&D Manager
Athlone
Athlone
Production Operator
Carlow
Carlow
Senior R&D Engineer
Galway
Galway
Quality Specialist
Clare
Clare
Senior R&D Engineer
Galway
Galway
R&D Senior Program Manager
Galway
Galway
Product Development Engineer
Dublin
Dublin
Principal Engineer
Dublin
Dublin
Regulatory Affairs Maanger
Galway
Galway
Manufacturing Engineer
Galway
Galway
Quality Systems Manager
Dublin
Dublin
Senior Quality Control Associate
Dublin South
Dublin South
Validation Engineer
Athlone
Athlone
Production Operator
Dublin
Dublin
CTO
Dublin
Dublin
Cleaning Validation Engineer
Carlow
Carlow
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
Product Development Engineer II
Athlone
Athlone
Product Development Engineer II
Athlone
Athlone
Quality Manager - NPI
Dublin
Dublin
R&D Engineer
Galway
Galway
Senior R&D Manager/Director
Dublin
Dublin
R&D Manager
Galway
Galway
Electronic Engineer
Dublin
Dublin
Change Control SME
Cork
Cork
Biomedical Engineer
Dublin
Dublin
R&D Engineer
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Principal Engineer
Dublin
Dublin
Injection Molding Engineer
North Leinster
North Leinster
Principal R&D Engineer
Galway
Galway
Senior R&D Engineer
Clare
Clare
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
Quality Operations Manager
Dublin
Dublin
Operations Engineer
Galway
Galway
Cleaning Validation Engineer
Carlow
Carlow
Production Operator
Meath
Meath
Electronic Engineer
Dublin
Dublin
Senior Mechanical Engineer
Dublin
Dublin
Senior Design Engineer
Dublin
Dublin
Senior Operations Engineer
Galway
Galway
Quality Engineer
Galway
Galway
Principal Engineer
Galway
Galway
Quality Technician
Dublin
Dublin
Production Operator
Meath
Meath
Maintenance Technician
Kilkenny
Kilkenny
Senior Project Engineer
Cavan
Cavan
R&D Technician
Galway
Galway
Program Manager
Galway
Galway
Reliability Engineer
Tipperary
Tipperary
Manufacturing Engineer
Galway
Galway
Production Operator
Dublin
Dublin
Quality Specialist
Clare
Clare
Senior Quality Engineer
Dublin
Dublin
EHS Systems Specialist
Dublin
Dublin
R&D Manager
Galway
Galway
R&D Manager
Galway
Galway
Lead Manufacturing Technician
Kilkenny
Kilkenny
Quality Control Technician
Carlow
Carlow
Manufacturing Technician
Clare
Clare
Electronic Design Engineer
Galway
Galway
Program Manager
Galway
Galway
Senior Quality Engineer
Leitrim
Leitrim
Senior QC Microbiology
Dublin
Dublin
Utilities Engineer - Black Utilities
Roscommon
Roscommon
Medical Writer
Cork
Cork
Mechanical Design Engineer
Germany
Germany
Biomedical Engineer
Dublin
Dublin
Senior R&D Manager
Athlone
Athlone
Regulatory Associate
Cork
Cork
Procurement Associate
Dublin
Dublin
Senior Maintenance Technician
Roscommon
Roscommon
Facilities Engineer
Carlow
Carlow
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
R&D Manager
Athlone
Athlone
Senior Project Engineer
Cavan
Cavan
NPI Process Engineer
Carlow
Carlow
Head of R&D
Galway
Galway
Director of Quality Engineering
Limerick
Limerick
Quality Assurance Engineer
Longford
Longford
Quality Engineer
Galway
Galway
R&D Manager
Galway
Galway
R&D Manager
Connaught
Connaught
Senior R&D Engineer
Galway
Galway
R&D Engineer
Galway
Galway
R&D Director
Galway
Galway
Senior Operations Engineer
Galway
Galway
Senior Quality Engineer
Galway
Galway
Quality Control NPI Senior Associate
Dublin South
Dublin South
Reliability Engineering Consultant - Rem
Republic of Ireland
Republic of Ireland
Design Assurance Engineer
Galway
Galway
Production Operator
Carlow
Carlow
Production Manager
Dublin
Dublin
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Senior Operations Engineer
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Manufacturing Technician
Clare
Clare
R&D Program Manager
Dublin
Dublin
Sourcing Specialist
Tipperary
Tipperary
Process Engineer
Galway
Galway
E&I Turnover Engineer
Carlow
Carlow
Quality Systems Specialist
Tipperary
Tipperary
Engineering Projects Lead
Carlow
Carlow
Project Engineer
Roscommon
Roscommon
Senior Manufacturing Manager
Dublin
Dublin
Principal R&D Engineer
Dublin
Dublin
R&D Manager
Galway
Galway
Reg Affairs Specialist
Clare
Clare
Quality Specialist
Tipperary
Tipperary
Senior R&D Engineer
Galway
Galway
NPI Process Engineer
Carlow
Carlow
Senior R&D Engineer
Galway
Galway
Quality Manager
Galway
Galway
Principal Process Equipment Engineer
Dublin South
Dublin South
Senior R&D Engineer
Galway
Galway
Senior QC Associate
Dublin
Dublin
R&D Technician II
Galway
Galway
Project Manager
Galway
Galway
Change Control Lead
Tipperary
Tipperary
Senior Design Engineer
Dublin
Dublin
QA Specialist (REMOTE)
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Project Manager
Kildare
Kildare
Senior R&D Engineer
Galway
Galway
Purchasing & Planning Manager
Wexford
Wexford
Senior Regulatory Affairs
Galway
Galway
Program Manager
Dublin
Dublin
R&D Engineer
Galway
Galway
Quality Specialist
Clare
Clare
Applications Scientist
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
QA Specialist (Hybrid)
Tipperary
Tipperary
Quality Engineer
Galway
Galway
QC Bioanalytical Analyst
Dublin North
Dublin North
Quality Control Technician
Carlow
Carlow
R&D Manager
Galway
Galway
Injection Moulding Engineer
Athlone
Athlone
Electronic Engineer
Dublin
Dublin
Reg Affairs Specialist
Connaught
Connaught
Senior R&D Engineer
Dublin
Dublin
R&D Engineer
Clare
Clare
QC Systems Specialist
Dublin
Dublin
R&D Director
Galway
Galway
Project Engineer
Limerick
Limerick
Product Development Engineer
Galway
Galway
Senior Microbiologist
Dublin
Dublin
Quality Director
Galway
Galway
Process Development Engineer
Galway
Galway
Senior QC 24/7 Shift
Dublin
Dublin
Senior Design Engineer
Dublin
Dublin
Project Manager - R&D
Galway
Galway
Principal Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Utilities Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
Maintenance Technician
Carlow
Carlow
Senior R&D Engineer
Galway
Galway
Senior Design Assurance Engineer
Athlone
Athlone
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Injection Moulding Engineer
Leitrim
Leitrim
Product Development Manager
Galway
Galway
R&D Engineer
Galway
Galway
Maintenance Technician
Kilkenny
Kilkenny
Senior Electronic Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Senior Engineering Manager
Limerick
Limerick
Senior R&D Engineer
Clare
Clare
Quality Manager
Galway
Galway
Process Chemist
Limerick
Limerick
R&D Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
R&D Manager
Galway
Galway
Project Manager - R&D
Galway
Galway
Territory Sales Specialist (Life Science
Belfast City
Belfast City
Quality Engineer
Galway
Galway
Manufacturing Technician
Clare
Clare
MS&T Associate Director
Dublin
Dublin
Product Development Engineer
Dublin
Dublin
Design Assurance Engineer
Galway
Galway
R&D Manager
Connaught
Connaught
Project Manager
Louth
Louth
Project Manager
Kildare
Kildare
Quality Engineer
Galway
Galway
Principal R&D Engineer
Galway
Galway
Principal Device Engineer
Dublin
Dublin
Quality Engineer
Galway
Galway
Scientist (hybrid)
Meath
Meath
Clean Utilities Engineer
Carlow
Carlow
Manufacturing Engineer
Wexford
Wexford
R&D Engineer
Galway
Galway
R&D Engineer
Galway
Galway
Principal Quality Engineer
Galway
Galway
Electronic Engineer
Dublin
Dublin
Senior Electronic Engineer
Dublin
Dublin
Electronic Engineer
Dublin
Dublin
R&D Engineer
Galway
Galway
Injection Moulding Engineer
Athlone
Athlone
Apply for this job
Details
Director of Regulatory Affairs
Reference: | JCAO0424 | Location: |
Galway |
Qualification: | Degree | Experience: | 10+ Years |
Job Type: | Permanent | Salary: | 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.
- 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.
- 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.
Laboratory Scientist Product Development Engineer Biopharmaceutical Scientist Manufacturing Executive Academic Medical Affairs Validation Engineer Clinical Research IT Pharma Sales Connected Health Sales and Marketing Supply Chain Microbiology PhD Packaging Engineer Biotechnology Quality Engineering Quality Assurance Mayo Allied Healthcare Medical Device Limerick Cork City Diagnostics Sales and Marketing Scientific Engineering Life Science Pharmaceutical Academic Supply Chain Project Manager Quality Control Chemistry Cork Dublin
Group sites:
Contract Jobs | Connected Health Jobs | Supply Chain Jobs | Scientific Jobs | Medical Device Jobs | Quality Assurance Jobs | Biopharmaceutical Jobs | Clinical Research Jobs | Medical Affairs Jobs | Science Jobs | Chemistry Jobs | Pharmaceutical Jobs | Biotechnology Jobs | Engineering Jobs
Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
Valid XHTML - CSS
Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
Valid XHTML - CSS






