
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 R&D Engineer
Galway
Galway
Process Development Engineer
Galway
Galway
Electronic Engineer
Dublin
Dublin
Product Development Engineer
Dublin
Dublin
Senior Design Engineer
Dublin
Dublin
Principal R&D Engineer
Dublin
Dublin
QA Manager
Canada
Canada
National Sales Manager
Dublin
Dublin
R&D Manager
Athlone
Athlone
Maintenance CMMS Engineer
Tipperary
Tipperary
Principal Quality Engineer
Galway
Galway
Project Engineer
Clare
Clare
Project Manager (hybrid)
Dublin
Dublin
Senior Mechanical Engineer
Dublin
Dublin
Injection Molding Engineer
North Leinster
North Leinster
Manufacturing Engineer
Galway
Galway
Senior Microbiologist
Dublin
Dublin
Manufacturing Engineer
Galway
Galway
Senior Operations Engineer
Galway
Galway
Quality Manager - Medical Devices
Limerick City
Limerick City
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
Engineering Business Manager
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Senior Regulatory Affairs
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Product Development Engineer
Galway
Galway
Manufacturing Technician
Clare
Clare
R&D Technician II
Galway
Galway
Quality Engineer
Galway
Galway
Principal R&D Engineer
Galway
Galway
Reliability Engineering Consultant - Rem
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Galway
Galway
Design Assurance Engineer
Galway
Galway
CTO
Dublin
Dublin
Product Development Engineer
Dublin
Dublin
Health & Safety Specialist
Dublin
Dublin
Injection Molding Engineer
North Leinster
North Leinster
Biomedical Engineer
Dublin
Dublin
Senior Operations Engineer
Galway
Galway
Change Control SME
Cork
Cork
Principal Software Engineer
Athlone
Athlone
Senior Equipment Engineer
Dublin
Dublin
R&D Manager
Connaught
Connaught
Quality Engineer
Galway
Galway
Engineering Shift Technician
Dublin
Dublin
CTO
Galway
Galway
Project Manager - R&D
Galway
Galway
Senior R&D Engineer
Galway
Galway
Product Development Engineer
Dublin
Dublin
Quality Technician
Dublin
Dublin
Senior Process Engineer
Dublin
Dublin
Injection Molding Engineer
North Leinster
North Leinster
Microbiology Manager
Dublin
Dublin
Senior Design Engineer
Dublin
Dublin
Senior Maintenance Technician
Roscommon
Roscommon
Senior R&D Engineer
Galway
Galway
Quality Manager
Galway
Galway
R&D Director
Galway
Galway
Principal R&D Engineer
Galway
Galway
Site Microbiologist
Republic of Ireland
Republic of Ireland
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Strategic Automation Lead
Waterford
Waterford
Documentation Specialist
Louth
Louth
Senior Project Engineer
Cavan
Cavan
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
Manufacturing Engineer
Wexford
Wexford
Quality Engineer
Galway
Galway
Product Development Manager
Galway
Galway
R&D Technician
Galway
Galway
Injection Molding Engineer
North Leinster
North Leinster
R&D Manager
Dublin
Dublin
Project Manager - R&D
Galway
Galway
Product Development Engineer
Galway
Galway
Principal Engineer
Dublin
Dublin
Utilities Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Quality Specialist
Clare
Clare
Senior R&D Engineer
Galway
Galway
Staff Systems Engineer
Limerick
Limerick
Senior Quality Engineer
Dublin
Dublin
R&D Engineer
Galway
Galway
Senior Quality Engineer
Leitrim
Leitrim
Injection Moulding Engineer
Leitrim
Leitrim
Operations Engineer
Galway
Galway
R&D Technician II
Galway
Galway
Senior Quality Engineer
Galway
Galway
Senior Validation Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Electronic Engineer
Dublin
Dublin
Maintenance Manufacturing Technician
Kilkenny
Kilkenny
Production Operator
Meath
Meath
Quality Operations Manager
Dublin
Dublin
Production Operator
Carlow
Carlow
Biomedical Engineer
Dublin
Dublin
R&D Engineer
Galway
Galway
R&D Manager
Galway
Galway
Quality Engineer
Athlone
Athlone
Senior R&D Engineer
Clare
Clare
Quality Engineer
Galway
Galway
Senior Quality Engineer
Leitrim
Leitrim
Quality Manager - NPI
Dublin
Dublin
Project Manager
Kildare
Kildare
Quality Engineer
Galway
Galway
Reg Affairs Specialist
Connaught
Connaught
Senior R&D Engineer
Galway
Galway
Injection Moulding Engineer
Athlone
Athlone
R&D Engineer
Galway
Galway
Regulatory Associate
Cork
Cork
Senior Design Assurance Engineer
Athlone
Athlone
Senior Quality Control Associate
Dublin South
Dublin South
Principal Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
QA Engineer
Leitrim
Leitrim
R&D Engineer
Galway
Galway
Production Manager
Dublin
Dublin
R&D Program Manager
Dublin
Dublin
R&D Engineer
Galway
Galway
Quality Technician
Dublin
Dublin
Process Engineer
Carlow
Carlow
Continuous Improvement Coach
Limerick
Limerick
Project Manager
Louth
Louth
Quality Specialist & Deputy RP
Limerick
Limerick
Electronic Engineer
Dublin
Dublin
Principal Engineer
Dublin
Dublin
Quality Systems Manager
Dublin
Dublin
Senior QA Specialist (hybrid)
Tipperary
Tipperary
Product Development Engineer
Galway
Galway
Injection Moulding Engineer
Athlone
Athlone
Senior R&D Manager
Athlone
Athlone
Project Engineer
Roscommon
Roscommon
Project Manager - R&D
Galway
Galway
E&I Turnover Engineer
Carlow
Carlow
Principal Device Engineer
Dublin
Dublin
Injection Moulding Engineer
Athlone
Athlone
Senior Engineering Manager
Limerick
Limerick
Principal Process Equipment Engineer
Dublin South
Dublin South
Manufacturing Technician
Clare
Clare
Quality Assurance Engineer
Longford
Longford
Senior R&D Engineer
Galway
Galway
R&D Engineer
Clare
Clare
Senior Electronic Engineer
Dublin
Dublin
Associate Director - Manufacturing &
Limerick
Limerick
Quality Engineer
Galway
Galway
R&D Manager
Galway
Galway
Maintenance & Reliability Technician
Limerick
Limerick
R&D Lifecycle Manager
Connaught
Connaught
Senior Operations Engineer
Galway
Galway
Procurement Associate
Dublin
Dublin
Manufacturing Engineer
Galway
Galway
R&D Senior Program Manager
Galway
Galway
Senior R&D Engineer
Galway
Galway
Principal R&D Engineer
Galway
Galway
Quality Engineer
Galway
Galway
Quality Technician
Dublin
Dublin
R&D Director
Galway
Galway
Principal Instrumentation & Calibrat
Limerick
Limerick
R&D Engineer
Galway
Galway
Project Manager - R&D
Galway
Galway
Responsible Person (RP)
Republic of Ireland
Republic of Ireland
Regulatory Affairs Maanger
Galway
Galway
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
R&D Manager
Connaught
Connaught
R&D Project Manager
Galway
Galway
Electronic Engineer
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
Senior Research & Development Engine
Limerick
Limerick
Quality Engineer
Athlone
Athlone
Product Development Engineer
Dublin
Dublin
Senior Electronic Engineer
Dublin
Dublin
R&D Manager
Connaught
Connaught
Electronic Engineer
Dublin
Dublin
Process Engineer
Galway
Galway
R&D Engineer
Galway
Galway
Project Manager - R&D
Galway
Galway
R&D Engineer
Galway
Galway
Quality Manager
Dublin
Dublin
Senior R&D Manager
Athlone
Athlone
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Senior Quality Engineer
Leitrim
Leitrim
Process Engineer
Dublin
Dublin
Project Manager
Kildare
Kildare
Manufacturing Technician
Clare
Clare
Principal R&D Engineer
Galway
Galway
Manufacturing Technician
Clare
Clare
DeltaV Technical Coordinator - Hybrid
Tipperary
Tipperary
Warehouse Operator
Meath
Meath
Electronic Engineer
Dublin
Dublin
Project Manager
Galway
Galway
Senior R&D Engineer
Galway
Galway
Quality Engineer
Wexford
Wexford
Senior Design Engineer
Dublin
Dublin
Analytical Scientist
Meath
Meath
Quality Engineer
Galway
Galway
Project Engineer
Cork
Cork
Principal R&D Engineer
Galway
Galway
Senior Project Engineer
Cavan
Cavan
R&D Director
Galway
Galway
Validation Engineer
Athlone
Athlone
Quality Manager
Dublin
Dublin
Quality Engineer
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Documentation Specialist
Louth
Louth
Senior Quality Engineer
Dublin
Dublin
Quality Specialist (Shift)
Dublin
Dublin
Senior QC Associate
Dublin
Dublin
Mechanical Technician
Carlow
Carlow
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Galway
Galway
Quality Engineer
Galway
Galway
Program Manager
Dublin
Dublin
Senior R&D Engineer
Clare
Clare
Embedded Software Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Quality Specialist
Tipperary
Tipperary
Team Leader - Lab Services
Dublin
Dublin
Senior Maintenance Technician
Kilkenny
Kilkenny
Senior R&D Engineer
Galway
Galway
Product Development Engineer
Dublin
Dublin
Team Leader - Lab Services
Dublin
Dublin
Design Quality Engineer
Galway
Galway
Purchasing & Planning Manager
Wexford
Wexford
R&D Engineer
Dublin
Dublin
Electronic Engineering
Dublin
Dublin
R&D Engineer
Galway
Galway
Quality Specialist
Clare
Clare
Senior R&D Engineer
Dublin
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Galway
Galway
Facilities Engineer
Carlow
Carlow
R&D Director
Galway
Galway
Quality Engineer
Athlone
Athlone
Process Chemist
Limerick
Limerick
R&D Manager
Athlone
Athlone
Product Development Engineer II
Athlone
Athlone
Senior R&D Engineer
Galway
Galway
Sourcing Specialist
Tipperary
Tipperary
R&D Engineer
Dublin
Dublin
R&D Manager
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Product Development Engineer II
Athlone
Athlone
Electronic Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
R&D Engineer
Galway
Galway
Maintenance & Reliability Technician
Limerick
Limerick
Product Development Engineer
Dublin
Dublin
Documentation Specialist
Louth
Louth
Senior Electronic Engineer
Dublin
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Product Development Engineer II
Athlone
Athlone
Director of Quality Engineering
Limerick
Limerick
Staff R&D Engineer
Limerick
Limerick
R&D Manager
Galway
Galway
Warehouse Operator
Meath
Meath
R&D Manager
Connaught
Connaught
Senior Electronics Engineer
Dublin
Dublin
Design Assurance Engineer
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Senior Quality Engineer
Galway
Galway
DeltaV Lead Automation Engineer
Tipperary
Tipperary
Documentation Specialist
Louth
Louth
R&D Manager
Galway
Galway
Calibration Technician
Republic of Ireland
Republic of Ireland
Senior Quality Engineer
Leitrim
Leitrim
Senior Electronics Engineer
Limerick
Limerick
Principal R&D Engineer
Dublin
Dublin
Quality Specialist
Clare
Clare
Purchasing & Planning Manager
Wexford
Wexford
Project Engineer
Limerick
Limerick
Purchasing & Planning Manager
Wexford
Wexford
Manufacturing Technician
Clare
Clare
Product Development Manager
Galway
Galway
Quality Engineer
Galway
Galway
Senior Maintenance Technician
Kilkenny
Kilkenny
Quality Manager
Galway
Galway
Electronic Engineer
Dublin
Dublin
MS&T Bioprocess Engineer
Meath
Meath
Apply for this job
Details
Senior Regulatroy Affairs Specialsit
Reference: | JCAO0926 | Location: |
Galway |
Qualification: | Degree | Experience: | 5-7 Years |
Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
Regulatory Affairs, Senior Regulatory Affairs Officer
Senior Regulatory Specialist
Our client a well funded high potential medical device start up are currently seeking experienced regulatory professional top join their team. The Senior Regulatory Affairs Specialist will work closely with a cross-functional team to obtain the regulatory approvals/clearances needed to support clinical and commercial use of an innovative new therapy.
Role/Responsibilities
- Support and advise the VP Quality and Regulatory Affairs by executing regulatory activities and developing regulatory strategies to support the needs of the business.
- Develop regulatory submissions to ensure timely product clearance/approval and lead preparation, review and submission of high-quality responses to questions from regulatory agencies.
- Collaborate with the development team to ensure that the data is created using best scientific principles and that submission goals are met.
- Develop and manage product design and technical documentation in compliance with the relevant regulations and standards, ensuring that data is controlled and is appropriately protected from corruption, misuse or damage.
- Assure compliance to applicable laws and regulations of all applicable Health Authorities related to obtaining product approval and maintaining product marketing rights.
- Monitor emerging legislation and guidance in appropriate jurisdictions and contribute to ensuring company-level awareness and compliance where appropriate.
Skills/Experience:
- A Bachelor’s or Master’s degree in a scientific or engineering discipline.
- At least 7 years’ experience in Quality Assurance or Regulatory Affairs for medical device companies, with a track record of success with IDE, FDA 510(k) and PMA submissions.
- Strong experience preparing and reviewing regulatory submissions to achieve timely approval.
- Collaborative team player with solid knowledge of the medical device design and development process.
- Excellent written, interpersonal communication and presentation skills.
- High level of organization with the ability to manage multiple projects.
- Able to apply excellent analytical and computer skills in conducting research, analysing data and writing technical documents -
For further information please contact James Cassidy [email protected] or call in confidence 086 0204322
Scientist Academic Academic Chemistry Dublin PhD Cork City Sales and Marketing Packaging Engineer Medical Device Pharmaceutical Project Manager IT Quality Control Scientific Diagnostics Quality Engineering Sales and Marketing Engineering Life Science Limerick Supply Chain Manufacturing Executive Quality Assurance Biopharmaceutical Microbiology Allied Healthcare Cork Supply Chain Medical Affairs Biotechnology Product Development Engineer Laboratory Scientist Pharma Sales Mayo Connected Health Validation Engineer Clinical Research
Group sites:
Engineering Jobs | Quality Assurance Jobs | Biopharmaceutical Jobs | Biotechnology Jobs | Scientific Jobs | Science Jobs | Contract Jobs | Medical Affairs Jobs | Chemistry Jobs | Medical Device Jobs | Supply Chain Jobs | Clinical Research Jobs | Connected Health Jobs | Pharmaceutical 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






