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
C&Q Lead
Tipperary
Tipperary
QC Bioassay Analyst (shift)
Carlow
Carlow
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Galway
Galway
Process Engineer
Cork
Cork
Recruitment Consultant
Wexford
Wexford
R&D Director
Galway
Galway
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Manufacturing Engineer
Galway
Galway
Quality Systems Manager
Dublin
Dublin
Validation Engineer
Carlow
Carlow
Principal R&D Engineer
Dublin
Dublin
Quality Manager - NPI
Dublin
Dublin
Quality Systems Specialist
Galway
Galway
Manufacturing Shift Lead
Donegal
Donegal
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
Senior Quality Engineer
Galway
Galway
Quality Manager
Clare
Clare
Engineering Shift Technician
Dublin
Dublin
Recruitment Consultant
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Galway
Galway
Project Engineer
Limerick
Limerick
Manager/ Senior Manager Drug Product Man
Republic of Ireland
Republic of Ireland
Quality Engineer
Wexford
Wexford
QC Analyst
Meath
Meath
Senior R&D Engineer
Galway
Galway
Product Development Engineer
Galway
Galway
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Qualified Person
Limerick
Limerick
Senior Process Enginer
Dublin South
Dublin South
Electrical Engineer
Limerick
Limerick
Senior R&D Engineer
Galway
Galway
Process Engineer (Shift)
Carlow
Carlow
QC Chemistry Analyst (Shift)
Carlow
Carlow
Operations Specialist
Louth
Louth
Quality Manager
Dublin
Dublin
QA Associate Specialist
Carlow
Carlow
Senior Engineering Manager
Limerick
Limerick
Project Process Engineer
Carlow
Carlow
Principal R&D Engineer
Dublin
Dublin
Electrical Engineer
Cork
Cork
Quality Engineer
Galway
Galway
EHS Project Lead
Cavan
Cavan
Senior Validation Engineer
Dublin
Dublin
Product Development Engineer
Galway
Galway
Senior Quality Engineer
Limerick
Limerick
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Senior Associate Quality Operations
Limerick
Limerick
Project Manager
Limerick
Limerick
Senior Quality Engineer
Dublin
Dublin
Biomedical Engineer
Dublin
Dublin
Senior EHS Specialist
Louth
Louth
Engineering Business Manager
Dublin
Dublin
Electronic Design Engineer
Galway
Galway
QC Chemistry Analyst
Carlow
Carlow
Packaging Engineer
Dublin
Dublin
Senior QC Associate
Dublin
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Quality Manager - NPI
Dublin
Dublin
Facilities Engineer
Carlow
Carlow
Production Operator
Carlow
Carlow
Clean Utilities Engineer
Carlow
Carlow
Project Manager - Suite Lead
Tipperary
Tipperary
Quality Manager
Dublin
Dublin
Product Development Engineer
Galway
Galway
Digital Lab Records Specialist
Tipperary
Tipperary
Quality Specialist (hybrid)
Tipperary
Tipperary
Senior Associate Quality Control
Dublin South
Dublin South
Sourcing Specialist
Tipperary
Tipperary
CQV Lead
Tipperary
Tipperary
Senior Electronic Engineer
Dublin
Dublin
E&I Turnover Engineer
Carlow
Carlow
Project Engineer
Clare
Clare
Project Manager - R&D
Galway
Galway
Manufacturing Engineer
Galway
Galway
Quality Technician
Carlow
Carlow
Process Engineer
Galway
Galway
R&D Director
Galway
Galway
Process Support Specialist
Carlow
Carlow
Principal R&D Engineer
Galway
Galway
R&D Manager
Galway
Galway
Graduate Laboratory Technician
Republic of Ireland
Republic of Ireland
Senior Electronic Engineer
Dublin
Dublin
Maintenance CMMS Engineer
Tipperary
Tipperary
R&D Director
Galway
Galway
Manufacturing Engineer
Limerick
Limerick
Senior R&D Engineer
Dublin
Dublin
Manufacturing Technician
Clare
Clare
Senior Technical Writer
Dublin
Dublin
Process Support Specialist
Carlow
Carlow
Senior R&D Engineer
Galway
Galway
Chemical Engineer
Tipperary
Tipperary
Principal R&D Engineer
Galway
Galway
Maintenance Engineer
Cork
Cork
Quality Systems Specialist
Dublin
Dublin
Head of R&D
Galway
Galway
Process Engineer
Limerick
Limerick
Distribution Centre Manager
Dublin
Dublin
Engineering Projects Lead
Carlow
Carlow
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
Laboratory & Quality Manager
Dublin
Dublin
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Dublin
Dublin
Microbiology Manager
Dublin
Dublin
Biomedical Engineer
Dublin
Dublin
Project Engineer
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Clare
Clare
Maintenance Reliability Engineer
Tipperary
Tipperary
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Senior Validation Engineer
Dublin
Dublin
Quality Technician
Dublin
Dublin
Process Development Engineer
Galway
Galway
Responsible Person (RP)
Republic of Ireland
Republic of Ireland
Process Support Specialist
Carlow
Carlow
Quality Validation Engineer
Limerick
Limerick
Senior R&D Project Manager
Galway
Galway
Specialist Operations Engineer
Tipperary
Tipperary
Product Development Engineer
Dublin
Dublin
Maintenance Planner
Carlow
Carlow
Senior QC 24/7 Shift
Dublin
Dublin
Senior Quality Engineer
Galway
Galway
Medical Device Director
Republic of Ireland
Republic of Ireland
Associate Quality Specialist
Tipperary
Tipperary
Senior Quality Engineer
Dublin
Dublin
E&I Turnover Engineer
Carlow
Carlow
Senior R&D Engineer
Dublin
Dublin
Senior Electrical Engineer
Galway
Galway
R&D Manager
Galway
Galway
Quality Engineer
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Senior Project Manager - Process Develop
Dublin South
Dublin South
Manufacturing Engineer
Wexford
Wexford
Clean Utilities Engineer
Carlow
Carlow
Quality Engineer
Athlone
Athlone
Clinical Affairs Manager
Galway
Galway
QC Bioanalytical Analyst
Dublin
Dublin
Design Assurance Engineer
Galway
Galway
Pharmaceutical Operator
Louth
Louth
Aseptic Process Lead
Carlow
Carlow
Senior R&D Manager/Director
Dublin
Dublin
Senior Quality Engineer-Remote
Republic of Ireland
Republic of Ireland
Quality Systems Enginer
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
R&D Manager
Galway
Galway
Senior Validation Engineer
Limerick
Limerick
Suite Team Delivery Lead
Tipperary
Tipperary
Principal Process Equipment Engineer
Dublin South
Dublin South
Product Development Engineer
Galway
Galway
Maintenance CMMS Engineer
Tipperary
Tipperary
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
QC Laboratory Technician
Carlow
Carlow
EHS Systems Specialist
Dublin
Dublin
Senior Electronics Engineer
Dublin
Dublin
Quality Technician
Dublin
Dublin
Trainer
Dublin
Dublin
Aseptic Process Lead
Carlow
Carlow
Senior R&D Engineer
Dublin
Dublin
Quality Engineer
Athlone
Athlone
Senior R&D Engineer
Clare
Clare
Aseptic Process Owner Lead
Dublin
Dublin
R&D Manager
Galway
Galway
Project Engineer
Tipperary
Tipperary
Senior Operations Engineer
Galway
Galway
Senior HVAC Engineer
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Senior Electronic Engineer
Dublin
Dublin
Maintenance Engineer
Carlow
Carlow
Associate Global Trade Ops
Dublin
Dublin
Program Manager
Cork
Cork
R&D Director
Galway
Galway
Engineering Manager
Clare
Clare
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
Director of Quality Engineering
Limerick
Limerick
Strategic Automation Lead
Waterford
Waterford
R&D Senior Program Manager
Galway
Galway
Validation Engineer
Limerick
Limerick
Production Operator
Carlow
Carlow
Senior Validation Engineer
Limerick
Limerick
R&D Program Manager
Dublin
Dublin
Facilities Engineer
Carlow
Carlow
Senior Regulatory Affairs
Galway
Galway
Automation Engineer
Cavan
Cavan
Quality Technician
Dublin
Dublin
Change Control Coordinator
Carlow
Carlow
Validation Engineer
Cork
Cork
Quality Specialist
Tipperary
Tipperary
Embedded Software Engineer
Dublin
Dublin
R&D Engineer
Dublin
Dublin
Graduate R&D Engineer
Galway
Galway
Senior Operations Manager
Tipperary
Tipperary
Senior Mechanical Engineer
Dublin
Dublin
EHS Systems Specialist
Carlow
Carlow
Project Manager
Louth
Louth
Associate Quality Specialist
Tipperary
Tipperary
Apply for this job
Details
Senior Regulatory Affairs
Reference: | JCAO1010 | Location: |
Galway |
Qualification: | Degree | Experience: | 4-5 Years |
Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
Regulatory Affairs, Senior Regulatory Affairs Officer
Our client a growing medical device organisation currently seeks a Senior Regulatory Affairs Specialist to join their team. The Senior Regulatory Affairs Specialist will be responsible for all regulatory activities including product certification and compliance, and for supporting the ongoing maintenance, audit and continuous improvement of specific elements of the Quality Management System
Role/Responsibilities
- Manage the regulatory and vigilance process.
- Prepare regulatory submissions for required markets coordinating input from other stakeholders, tracking and supporting product clearances and certification to completion.
- Maintain technical files for all cleared products.
- Support the Senior Quality & Regulatory Manager in managing any required product certification testing.
- Support the Senior Quality & Regulatory Manager in managing the Risk Management process for all existing and new products.
- Complaints handling for medical reporting and filing to the appropriate competent authorities.
- Keep up to date with changing regulatory and compliance requirements e.g., REACH ROHS2 etc.
- Maintain environmental registrations for all markets.
- Support labelling and packaging updates and creations from a regulatory and clinical claims perspective.
- Complete internal audits as required and lead CE technical file audits for the company.
- Support the Quality team in maintaining the QMS
- Expert Knowledge of regulatory processes for EU, UK and FDA product clearance.
- Working experience of regulatory processes for ROW markets.
- Working experience of a certified Quality Management System.
Skills/Experience:
- You will have a third level degree and a significant amount of experience in medical devices.
- A post-graduate qualification in Quality Assurance along with experience of active medical devices would be an advantage.
- Significant regulatory affairs experience including experience of international regulatory processes.
- In depth knowledge of product certification testing requirements for active Medical Devices.
- In depth knowledge of maintaining a certified Quality Management System.
- Knowledge and application of Quality tools and Methodologies including lean six sigma, TQM etc.
- Experience of EN/MDD/MDR, ISO13485 and FDA requirements.
- Trained QMS Internal Auditor.
- Strong attention to detail.
- Excellent Verbal and written communication skills.
- Results orientated and a self-starter with the ability to work on own initiative.
- Knowledge of and commitment to continuous improvement and problem solving.
- Promote best practice and knowledge of the QSR and ISO/MDD standards.
- Advanced Microsoft Office and reporting tool skills.
- Strong project management skills.
For further information please contact James Cassidy [email protected] or call in confidence [email protected]
Medical Device Scientist Scientific Product Development Engineer Sales and Marketing Academic Mayo Validation Engineer PhD Cork City Pharma Sales Chemistry Dublin Cork Connected Health Manufacturing Executive Allied Healthcare Project Manager Biopharmaceutical Diagnostics Academic Packaging Engineer Quality Assurance Supply Chain Microbiology Quality Control Limerick IT Pharmaceutical Biotechnology Sales and Marketing Laboratory Scientist Clinical Research Quality Engineering Supply Chain Medical Affairs Engineering Life Science
Group sites:
Biopharmaceutical Jobs | Medical Device Jobs | Engineering Jobs | Chemistry Jobs | Contract Jobs | Scientific Jobs | Supply Chain Jobs | Pharmaceutical Jobs | Medical Affairs Jobs | Quality Assurance Jobs | Clinical Research Jobs | Science Jobs | Biotechnology Jobs | Connected Health 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