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
Project Engineer
Tipperary
Tipperary
Graduate R&D Engineer
Galway
Galway
Quality Engineer
Athlone
Athlone
Project Process Engineer
Carlow
Carlow
Project Engineer
Limerick
Limerick
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
Program Manager
Cork
Cork
Senior R&D Manager/Director
Dublin
Dublin
Quality Manager
Dublin
Dublin
Quality Technician
Dublin
Dublin
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Project Manager
Louth
Louth
Associate Quality Specialist
Tipperary
Tipperary
Quality Systems Enginer
Dublin
Dublin
Process Support Specialist
Carlow
Carlow
QC Chemistry Analyst (Shift)
Carlow
Carlow
Process Engineer
Cork
Cork
R&D Director
Galway
Galway
Quality Engineer
Athlone
Athlone
Director of Quality Engineering
Limerick
Limerick
Quality Systems Manager
Dublin
Dublin
Aseptic Process Lead
Carlow
Carlow
Pharmaceutical Operator
Louth
Louth
Clean Utilities Engineer
Carlow
Carlow
Quality Technician
Dublin
Dublin
Sourcing Specialist
Tipperary
Tipperary
E&I Turnover Engineer
Carlow
Carlow
QC Analyst
Meath
Meath
Facilities Engineer
Carlow
Carlow
Principal R&D Engineer
Galway
Galway
Senior Operations Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
EHS Project Lead
Cavan
Cavan
Product Development Engineer
Dublin
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Senior Associate Quality Operations
Limerick
Limerick
Responsible Person (RP)
Republic of Ireland
Republic of Ireland
Quality Technician
Dublin
Dublin
Chemical Engineer
Tipperary
Tipperary
Senior QC 24/7 Shift
Dublin
Dublin
Validation Engineer
Limerick
Limerick
Operations Specialist
Louth
Louth
Senior Quality Engineer-Remote
Republic of Ireland
Republic of Ireland
Project Manager
Limerick
Limerick
Quality Manager
Dublin
Dublin
Associate Quality Specialist
Tipperary
Tipperary
Trainer
Dublin
Dublin
Process Engineer
Limerick
Limerick
R&D Director
Galway
Galway
Quality Manager - NPI
Dublin
Dublin
Recruitment Consultant
Republic of Ireland
Republic of Ireland
Senior Validation Engineer
Limerick
Limerick
QC Bioassay Analyst (shift)
Carlow
Carlow
R&D Senior Program Manager
Galway
Galway
Process Support Specialist
Carlow
Carlow
Project Manager - R&D
Galway
Galway
Quality Manager
Clare
Clare
Senior R&D Engineer
Dublin
Dublin
Manager/ Senior Manager Drug Product Man
Republic of Ireland
Republic of Ireland
Principal Process Equipment Engineer
Dublin South
Dublin South
Digital Lab Records Specialist
Tipperary
Tipperary
Manufacturing Engineer
Wexford
Wexford
Maintenance CMMS Engineer
Tipperary
Tipperary
Senior R&D Engineer
Galway
Galway
Production Operator
Carlow
Carlow
Senior Electronics Engineer
Dublin
Dublin
EHS Systems Specialist
Dublin
Dublin
Quality Validation Engineer
Limerick
Limerick
Senior R&D Engineer
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Senior Validation Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Quality Engineer
Wexford
Wexford
Qualified Person
Limerick
Limerick
Production Operator
Carlow
Carlow
R&D Manager
Galway
Galway
Quality Systems Specialist
Dublin
Dublin
Manufacturing Shift Lead
Donegal
Donegal
Maintenance Engineer
Carlow
Carlow
Senior EHS Specialist
Louth
Louth
Suite Team Delivery Lead
Tipperary
Tipperary
Senior Electronic Engineer
Dublin
Dublin
E&I Turnover Engineer
Carlow
Carlow
Graduate Laboratory Technician
Republic of Ireland
Republic of Ireland
Aseptic Process Owner Lead
Dublin
Dublin
Senior R&D Engineer
Clare
Clare
Senior Regulatory Affairs
Galway
Galway
R&D Manager
Galway
Galway
Senior Electronic Engineer
Dublin
Dublin
Manufacturing Engineer
Limerick
Limerick
Aseptic Process Lead
Carlow
Carlow
Quality Manager - NPI
Dublin
Dublin
Product Development Engineer
Galway
Galway
Senior Validation Engineer
Dublin
Dublin
Manufacturing Engineer
Galway
Galway
QC Laboratory Technician
Carlow
Carlow
Biomedical Engineer
Dublin
Dublin
Maintenance Planner
Carlow
Carlow
QA Associate Specialist
Carlow
Carlow
R&D Engineer
Dublin
Dublin
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
Specialist Operations Engineer
Tipperary
Tipperary
Senior Mechanical Engineer
Dublin
Dublin
Project Manager - Suite Lead
Tipperary
Tipperary
Electrical Engineer
Cork
Cork
Senior R&D Project Manager
Galway
Galway
Product Development Engineer
Galway
Galway
Quality Specialist
Tipperary
Tipperary
Quality Systems Specialist
Galway
Galway
C&Q Lead
Tipperary
Tipperary
R&D Director
Galway
Galway
R&D Director
Galway
Galway
Senior Operations Manager
Tipperary
Tipperary
Product Development Engineer
Galway
Galway
R&D Manager
Galway
Galway
Senior HVAC Engineer
Dublin
Dublin
Change Control Coordinator
Carlow
Carlow
Manufacturing Technician
Clare
Clare
QC Chemistry Analyst
Carlow
Carlow
Senior Validation Engineer
Limerick
Limerick
Senior Process Enginer
Dublin South
Dublin South
Maintenance Reliability Engineer
Tipperary
Tipperary
Senior R&D Engineer
Galway
Galway
Facilities Engineer
Carlow
Carlow
Principal R&D Engineer
Dublin
Dublin
Strategic Automation Lead
Waterford
Waterford
Clinical Affairs Manager
Galway
Galway
CQV Lead
Tipperary
Tipperary
R&D Manager
Galway
Galway
Senior Engineering Manager
Limerick
Limerick
Manufacturing Engineer
Galway
Galway
Validation Engineer
Cork
Cork
Project Engineer
Republic of Ireland
Republic of Ireland
Medical Device Director
Republic of Ireland
Republic of Ireland
Process Support Specialist
Carlow
Carlow
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
Project Engineer
Clare
Clare
Biomedical Engineer
Dublin
Dublin
EHS Systems Specialist
Carlow
Carlow
Senior Project Manager - Process Develop
Dublin South
Dublin South
Recruitment Consultant
Wexford
Wexford
Senior R&D Engineer
Dublin
Dublin
Laboratory & Quality Manager
Dublin
Dublin
Senior Associate Quality Control
Dublin South
Dublin South
Senior Quality Engineer
Dublin
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Quality Engineer
Galway
Galway
Distribution Centre Manager
Dublin
Dublin
Product Development Engineer
Galway
Galway
Principal R&D Engineer
Dublin
Dublin
Electronic Design Engineer
Galway
Galway
Senior Electronic Engineer
Dublin
Dublin
Process Development Engineer
Galway
Galway
Automation Engineer
Cavan
Cavan
Packaging Engineer
Dublin
Dublin
Engineering Manager
Clare
Clare
Clean Utilities Engineer
Carlow
Carlow
Process Engineer
Galway
Galway
Senior Quality Engineer
Galway
Galway
Senior Quality Engineer
Galway
Galway
Quality Specialist (hybrid)
Tipperary
Tipperary
Senior R&D Engineer
Clare
Clare
Quality Engineer
Galway
Galway
Embedded Software Engineer
Dublin
Dublin
Senior Electrical Engineer
Galway
Galway
Engineering Projects Lead
Carlow
Carlow
Process Engineer (Shift)
Carlow
Carlow
Senior Technical Writer
Dublin
Dublin
Engineering Shift Technician
Dublin
Dublin
Senior Quality Engineer
Limerick
Limerick
Microbiology Manager
Dublin
Dublin
Maintenance CMMS Engineer
Tipperary
Tipperary
Principal R&D Engineer
Galway
Galway
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Dublin
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Electrical Engineer
Limerick
Limerick
Maintenance Engineer
Cork
Cork
Quality Technician
Carlow
Carlow
Senior R&D Engineer
Galway
Galway
Engineering Business Manager
Dublin
Dublin
Associate Global Trade Ops
Dublin
Dublin
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
Senior Quality Engineer
Dublin
Dublin
R&D Program Manager
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Head of R&D
Galway
Galway
QC Bioanalytical Analyst
Dublin
Dublin
Validation Engineer
Carlow
Carlow
Design Assurance Engineer
Galway
Galway
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Senior QC Associate
Dublin
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
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
Engineering Academic IT Mayo Sales and Marketing Medical Device Biotechnology Supply Chain Microbiology Packaging Engineer Supply Chain Biopharmaceutical Product Development Engineer Academic Quality Assurance Medical Affairs PhD Life Science Clinical Research Diagnostics Validation Engineer Sales and Marketing Quality Engineering Laboratory Scientist Cork City Project Manager Cork Manufacturing Executive Chemistry Limerick Scientist Pharma Sales Quality Control Allied Healthcare Connected Health Scientific Pharmaceutical Dublin
Group sites:
Quality Assurance Jobs | Pharmaceutical Jobs | Biotechnology Jobs | Medical Affairs Jobs | Supply Chain Jobs | Engineering Jobs | Medical Device Jobs | Chemistry Jobs | Scientific Jobs | Connected Health Jobs | Science Jobs | Contract Jobs | Biopharmaceutical Jobs | Clinical Research 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