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 Quality Engineer
Galway
Galway
Sourcing Specialist
Tipperary
Tipperary
Process Support Specialist
Carlow
Carlow
Senior R&D Manager/Director
Dublin
Dublin
Chemical Engineer
Tipperary
Tipperary
EHS Project Lead
Cavan
Cavan
Lab Systems Specialist
Tipperary
Tipperary
Process Support Specialist
Carlow
Carlow
Facilities Engineer
Carlow
Carlow
Validation Engineer
Carlow
Carlow
Clinical Affairs Manager
Galway
Galway
Senior HVAC Engineer
Dublin
Dublin
Principal R&D Engineer
Galway
Galway
Manufacturing Shift Lead
Donegal
Donegal
Process Engineer (Shift)
Carlow
Carlow
Clean Utilities Engineer
Carlow
Carlow
Electrical Engineer
Limerick
Limerick
Quality Manager
Clare
Clare
Senior R&D Engineer
Galway
Galway
Senior Engineering Manager
Limerick
Limerick
Senior R&D Engineer
Galway
Galway
Senior Quality Engineer
Galway
Galway
Head of R&D
Galway
Galway
Quality Manager - NPI
Dublin
Dublin
Associate Quality Specialist
Tipperary
Tipperary
R&D Manager
Galway
Galway
Senior Mechanical Engineer
Dublin
Dublin
Senior Validation Engineer
Limerick
Limerick
Quality Technician
Dublin
Dublin
Embedded Software Engineer
Dublin
Dublin
Manufacturing Engineer
Galway
Galway
Maintenance Engineer
Carlow
Carlow
Senior R&D Engineer
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
R&D Manager
Galway
Galway
Principal R&D Engineer
Galway
Galway
Product Development Engineer
Galway
Galway
Microbiology Manager
Dublin
Dublin
Recruitment Consultant
Wexford
Wexford
Program Manager
Cork
Cork
Process Development Engineer
Galway
Galway
Biomedical Engineer
Dublin
Dublin
Specialist Operations Engineer
Tipperary
Tipperary
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Senior Quality Engineer
Galway
Galway
Client Project Manager
Louth
Louth
Facilities Engineer
Carlow
Carlow
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
Distribution Centre Manager
Dublin
Dublin
Biomedical Engineer
Dublin
Dublin
Quality Manager
Dublin
Dublin
R&D Manager
Galway
Galway
Senior Quality Engineer
Galway
Galway
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Change Control Coordinator
Carlow
Carlow
Project Engineer
Republic of Ireland
Republic of Ireland
Project Process Engineer
Carlow
Carlow
QA Specialist
Cork
Cork
Quality Systems Manager
Dublin
Dublin
Aseptic Process Lead
Carlow
Carlow
Maintenance Planner
Carlow
Carlow
Senior R&D Engineer
Galway City
Galway City
Senior Mechanical Engineer
Dublin
Dublin
Senior QC 24/7 Shift
Dublin
Dublin
Senior Electronic Engineer
Dublin
Dublin
Process Support Specialist
Carlow
Carlow
Principal Process Equipment Engineer
Dublin South
Dublin South
QA Associate Specialist
Carlow
Carlow
Quality Engineer
Athlone
Athlone
Qualified Person
Limerick
Limerick
Process Engineer
Limerick
Limerick
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
Project Engineer
Limerick
Limerick
Senior EHS Specialist
Louth
Louth
Senior Electronics Engineer
Dublin
Dublin
Manufacturing Engineer
Limerick
Limerick
Quality Manager
Dublin
Dublin
Senior Validation Engineer
Dublin
Dublin
Quality Systems Specialist
Galway
Galway
R&D Director
Galway
Galway
Electrical Engineer
Cork
Cork
Senior Operations Manager
Tipperary
Tipperary
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
R&D Program Manager
Dublin
Dublin
Project Engineer
Clare
Clare
Senior R&D Engineer
Clare
Clare
Senior Regulatory Affairs
Galway
Galway
Quality Validation Engineer
Limerick
Limerick
Quality Technician
Dublin
Dublin
Validation Engineer
Limerick
Limerick
Engineering Projects Lead
Carlow
Carlow
EHS Systems Specialist
Carlow
Carlow
Project Manager - Suite Lead
Tipperary
Tipperary
Senior Process Enginer
Dublin South
Dublin South
Quality Systems Specialist
Dublin
Dublin
Quality Engineer
Galway
Galway
Trainer
Dublin
Dublin
Product Development Engineer
Galway
Galway
Engineering Shift Technician
Dublin
Dublin
Director of Quality Engineering
Limerick
Limerick
Senior R&D Engineer
Clare
Clare
Embedded Software Engineer
Dublin
Dublin
R&D Director
Galway
Galway
Manufacturing Specialist
Dublin
Dublin
R&D Engineer
Dublin
Dublin
Associate Global Trade Ops
Dublin
Dublin
EHS Systems Specialist
Dublin
Dublin
Suite Team Delivery Lead
Tipperary
Tipperary
Clean Utilities Engineer
Carlow
Carlow
Associate Director Quality Assurance
Limerick
Limerick
Senior Electrical Engineer
Galway
Galway
Senior Electronic Engineer
Dublin
Dublin
Process Engineer
Cork
Cork
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Maintenance Reliability Engineer
Tipperary
Tipperary
Production Operator
Carlow
Carlow
Project Manager
Louth
Louth
Senior Quality Engineer
Dublin
Dublin
Aseptic Process Owner Lead
Dublin
Dublin
Manufacturing Engineer
Galway
Galway
Production Operator
Carlow
Carlow
Maintenance CMMS Engineer
Tipperary
Tipperary
Senior Associate Quality Operations
Limerick
Limerick
Senior Validation Engineer
Dublin
Dublin
Quality Technician
Carlow
Carlow
Process Engineer
Galway
Galway
Principal R&D Engineer
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
QC Chemistry Analyst (Shift)
Carlow
Carlow
Quality Manager - NPI
Dublin
Dublin
Project Engineer
Tipperary
Tipperary
Embedded Software Engineer
Athlone
Athlone
R&D Director
Galway
Galway
Senior Technical Writer
Dublin
Dublin
Electronic Design Engineer
Galway
Galway
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
E&I Turnover Engineer
Carlow
Carlow
R&D Senior Program Manager
Galway
Galway
R&D Manager
Galway
Galway
Biomedical Engineer
Dublin
Dublin
Senior Quality Engineer-Remote
Republic of Ireland
Republic of Ireland
Quality Engineer
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Product Development Engineer
Galway
Galway
QC Laboratory Technician
Carlow
Carlow
Quality Engineer
Athlone
Athlone
Senior QA Associate - Operations
Limerick
Limerick
Product Development Engineer
Galway
Galway
Product Development Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Project Manager - R&D
Galway
Galway
Operations Specialist
Louth
Louth
Senior QC Associate
Dublin
Dublin
Quality Specialist
Tipperary
Tipperary
E&I Turnover Engineer
Carlow
Carlow
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
Quality Systems Enginer
Dublin
Dublin
Biomedical Engineer
Dublin
Dublin
Project Manager
Limerick
Limerick
Responsible Person (RP)
Republic of Ireland
Republic of Ireland
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Engineering Business Manager
Dublin
Dublin
Manufacturing Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
Product Development Engineer
Galway
Galway
Quality Engineer
Wexford
Wexford
R&D Director
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Analytical Chemist
Tipperary
Tipperary
Principal R&D Engineer
Dublin
Dublin
Senior Quality Engineer
Limerick
Limerick
Production Operator
Louth
Louth
Medical Device Director
Republic of Ireland
Republic of Ireland
Biomedical Engineer
Dublin
Dublin
Validation Engineer
Cork
Cork
Senior Validation Engineer
Limerick
Limerick
Recruitment Consultant
Republic of Ireland
Republic of Ireland
Automation Engineer
Cavan
Cavan
Planner/Scheduler
Cork
Cork
Senior Quality Engineer
Dublin
Dublin
C&Q Lead
Tipperary
Tipperary
Digital Lab Records Specialist
Tipperary
Tipperary
Associate Quality Specialist
Tipperary
Tipperary
Senior R&D Engineer
Dublin
Dublin
CQV Lead
Tipperary
Tipperary
Strategic Automation Lead
Waterford
Waterford
Senior R&D Engineer
Dublin
Dublin
Manufacturing Engineer
Wexford
Wexford
Senior Quality Engineer
Dublin
Dublin
Senior R&D Project Manager
Galway
Galway
Maintenance Engineer
Cork
Cork
QC Bioassay Analyst (shift)
Carlow
Carlow
Engineering Manager
Clare
Clare
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Maintenance CMMS Engineer
Tipperary
Tipperary
Manufacturing Technician
Clare
Clare
Packaging Engineer
Dublin
Dublin
Senior Associate Quality Control
Dublin South
Dublin South
Apply for this job
Details
Senior Regulatory Affairs Specialist
Reference: | JCAO1229 | Location: |
Dublin |
Qualification: | Degree | Experience: | 4-5 Years |
Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
QA RA Engineer, Senior Regulatory Affairs Officer
Senior Regulatory Affairs Specialist
Our client a high potential medical device start up current seeks a Senior Regulatroy Affairs Specialist to join their team. Reporting to the Director of Quality and Regulatory Affairs the Senior Regulatory Affairs will take an active role in developing the Regulatory strategy in Europe and the US and interacting with the relevant Regulatory and Notified Bodies. They will also be required to help maintain the Design History Fileof Class III implant. This position offers the opportunity to join in an exciting early stage company developing a novel cardiovascular device
Role and responsibilities:
- Support the creation & maintenance of product design and technical documentation in compliance with the relevant regulations and standards (Class III, animal derived, implantable devices). This includes providing guidance to and coordinating inputs from the technical experts on each design project.
- Support the development and submission of high quality clinical and regulatory files to the relevant ethical committees and regulatory agencies, ensuring successful approval.
- Organise and maintain regulatory and clinical submissions with regulatory authorities, ethical committees, and clinical investigation sites.
- Co-ordinate and, where appropriate, conduct gap assessment activities in line with updated regulatory requirements and standards.
- Keep up to date with changes in applicable regulatory requirements and standards.
- Assist company preparation for inspection by notified body and regulatory authorities.
- Support implementation and maintenance of a robust and fully compliant quality system in accordance with ISO 13485, including risk management.
- Continuous improvement of the Quality Management System to meet the requirements of all stakeholders.
- Co-ordinate and progress Adverse Event reporting to regulatory authorities as required by QA/RA Director.
- Administrate the processes for the control of product information, including labelling, Instructions For Use (IFU), and user training.
- Ensuring adherence to all organisational and external regulatory requirements.
Skills/Experience:
- Bachelor degree in science, engineering or related field
- Proven track record in a similar role with a minimum of 5 years in medical device Regulatory Affairs
- Extensive knowledge of quality management systems, design controls per ISO 13485 and current International and European regulations/standards with respect to medical devices.
- In depth knowledge of the EU Medical Device Directive and MEDDEV guidance documents
- Experience in design, verification and process validation processes
- Prior experience and knowledge in GMP, process validation, change control, CAPA and electronic document control systems
- Prior experience in class III medical products highly preferred
- Prior experience in a medical device start up preferred.
- Good leadership and project management skills with the ability and willingness to effectively build and manage a small team. Experience in people management and development.
- Excellent verbal and written communication skills
For further information please contact James Cassidy [email protected] or call 0860204322
Academic Validation Engineer Supply Chain PhD Laboratory Scientist Limerick Medical Affairs Cork Engineering Scientist Cork City Dublin Microbiology Quality Control Supply Chain Life Science Academic Packaging Engineer Sales and Marketing Connected Health Diagnostics Scientific Product Development Engineer IT Chemistry Manufacturing Executive Pharmaceutical Project Manager Sales and Marketing Medical Device Clinical Research Biopharmaceutical Pharma Sales Quality Assurance Quality Engineering Biotechnology Allied Healthcare Mayo
Group sites:
Quality Assurance Jobs | Contract Jobs | Chemistry Jobs | Engineering Jobs | Biopharmaceutical Jobs | Pharmaceutical Jobs | Connected Health Jobs | Clinical Research Jobs | Biotechnology Jobs | Medical Affairs Jobs | Medical Device Jobs | Science Jobs | Supply Chain Jobs | Scientific 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