
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
Clean Utilities Engineer
Carlow
Carlow
R&D Engineer
Galway
Galway
Product Development Engineer II
Athlone
Athlone
Electronic Engineer
Dublin
Dublin
R&D Director
Galway
Galway
R&D Engineer
Galway
Galway
Project Manager - R&D
Galway
Galway
Quality Engineer
Galway
Galway
Product Development Engineer
Galway
Galway
Senior QA Associate (Shift)
Dublin
Dublin
Senior Quality Engineer
Leitrim
Leitrim
Quality Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
Principal R&D Engineer
Galway
Galway
R&D Technician
Galway
Galway
QA Manager
Canada
Canada
Product Development Engineer
Dublin
Dublin
Lead Project Engineer
Carlow
Carlow
Senior Design Engineer
Dublin
Dublin
R&D Engineer
Dublin
Dublin
Manufacturing Engineer
Galway
Galway
R&D Engineer
Galway
Galway
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Galway
Galway
Operations Manager
Galway
Galway
MS&T Bioprocess Engineer
Meath
Meath
Biostatistician
Dublin City Centre
Dublin City Centre
DeltaV Lead Automation Engineer
Tipperary
Tipperary
Quality Manager
Galway
Galway
Mechanical Design Engineer
Germany
Germany
Manufacturing Engineer
Galway
Galway
Operations Engineer
Galway
Galway
Reliability Engineering Consultant - Rem
Republic of Ireland
Republic of Ireland
Program Manager
Dublin
Dublin
Quality Engineer
Galway
Galway
Senior Quality Engineer
Leitrim
Leitrim
Quality Technician
Dublin
Dublin
Senior Analytical Specialist
Limerick
Limerick
Senior Electronics Engineer
Limerick
Limerick
Quality Management Specialist - External
Dublin South
Dublin South
Biomedical Engineer
Dublin
Dublin
R&D Engineer
Galway
Galway
Quality Control Technician
Carlow
Carlow
Senior R&D Project Manager
Galway
Galway
Quality Engineer
Galway
Galway
R&D Manager
Athlone
Athlone
Facilities Engineer
Carlow
Carlow
Head of R&D
Galway
Galway
Principal Equipment Engineer
Dublin
Dublin
Quality Engineer
Athlone
Athlone
Senior Microbiologist
Dublin
Dublin
Operations Engineer
Galway
Galway
Project Manager - R&D
Galway
Galway
Principal Equipment Engineer
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
Quality Systems Manager
Dublin
Dublin
Principal Engineer - R&D
Galway
Galway
Associate R&D Engineer
Galway
Galway
Senior Engineering Manager
Limerick
Limerick
Quality Manager - NPI
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Injection Moulding Engineer
Athlone
Athlone
Senior Design Engineer
Dublin
Dublin
R&D Engineer
Dublin
Dublin
Electronic Engineer
Dublin
Dublin
Manufacturing Technician
Clare
Clare
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
Manufacturing Engineer
Galway
Galway
Injection Molding Engineer
North Leinster
North Leinster
Product Development Manager
Galway
Galway
Director of Quality Engineering
Limerick
Limerick
Senior QC Associate
Dublin
Dublin
Process Safety Specialist
Tipperary
Tipperary
Senior Electronic Engineer
Dublin
Dublin
Injection Moulding Engineer
Athlone
Athlone
R&D Senior Program Manager
Galway
Galway
Senior R&D Engineer
Clare
Clare
Quality Engineer
Athlone
Athlone
Principal Engineer - R&D
Galway
Galway
Engineering Business Manager
Dublin
Dublin
Senior R&D Manager
Athlone
Athlone
Principal Equipment Engineer
Dublin
Dublin
Quality Engineer
Galway
Galway
Engineering Projects Lead
Carlow
Carlow
Senior Electronic Engineer
Dublin
Dublin
Sourcing Specialist
Tipperary
Tipperary
Quality Specialist
Clare
Clare
Maintenance CMMS Engineer
Tipperary
Tipperary
E&I Turnover Engineer
Carlow
Carlow
Senior Operations Engineer
Galway
Galway
QA Engineer
Leitrim
Leitrim
Electronic Engineer
Dublin
Dublin
Microbiology Manager
Dublin
Dublin
Senior Regulatory Affairs
Galway
Galway
Investigation Lead
Dublin
Dublin
R&D Director
Galway
Galway
Technical Administrator
Tipperary
Tipperary
Senior Maintenance Technician
Roscommon
Roscommon
Project Manager - R&D
Galway
Galway
Product Development Engineer II
Athlone
Athlone
Senior R&D Engineer
Galway
Galway
Principal Equipment Engineer
Dublin
Dublin
Global Safety Senior Manager
Dublin
Dublin
NPI Process Engineer
Carlow
Carlow
Injection Molding Engineer
North Leinster
North Leinster
Principal Equipment Engineer
Dublin
Dublin
Process Engineer (NPI)
Carlow
Carlow
Quality Engineer
Galway
Galway
Principal Equipment Engineer
Dublin
Dublin
Senior QC Microbiology
Dublin
Dublin
R&D Manager
Galway
Galway
Maintenance Technician
Carlow
Carlow
Account Manager UK and Ireland
Republic of Ireland
Republic of Ireland
Principal R&D Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
Senior Quality Engineer
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Senior Electronic Engineer
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Product Development Engineer
Dublin
Dublin
Quality Control Technician
Carlow
Carlow
Senior R&D Engineer
Dublin
Dublin
Senior R&D Manager
Athlone
Athlone
EHS Systems Specialist
Dublin
Dublin
Quality Manager
Galway
Galway
Electronic Engineer
Dublin
Dublin
Principal Process Equipment Engineer
Dublin South
Dublin South
R&D Engineer
Galway
Galway
Process Engineer
Galway
Galway
Product Development Engineer
Dublin
Dublin
Project Engineer
Limerick
Limerick
R&D Engineer
Galway
Galway
Maintenance Technician
Kilkenny
Kilkenny
R&D Technician II
Galway
Galway
Principal R&D Engineer
Dublin
Dublin
R&D Manager
Dublin
Dublin
Quality Assurance Engineer
Longford
Longford
SAP Analyst - Logistics & Supply Cha
Limerick
Limerick
Associate R&D Engineer
Galway
Galway
Project Engineer
Clare
Clare
Utilities Engineer
Dublin
Dublin
Product Development Engineer
Dublin
Dublin
MS&T Associate Director
Dublin
Dublin
Senior Quality Engineer-Remote
Republic of Ireland
Republic of Ireland
Quality Engineer
Galway
Galway
Quality Manager - Medical Devices
Limerick City
Limerick City
Production Operator
Dublin
Dublin
R&D Project Manager
Galway
Galway
Reliability Engineer
Tipperary
Tipperary
Senior QC 24/7 Shift
Dublin
Dublin
Quality Engineer
Galway
Galway
Product Development Engineer II
Athlone
Athlone
Senior Equipment Engineer
Dublin
Dublin
Principal Equipment Engineer
Dublin
Dublin
Quality Systems Specialist
Tipperary
Tipperary
Quality Manager
Dublin
Dublin
Quality Technician
Dublin
Dublin
Manufacturing Technician
Clare
Clare
Process Chemist
Limerick
Limerick
Injection Molding Engineer
North Leinster
North Leinster
Process Engineer
Cork
Cork
Senior Quality Engineer
Leitrim
Leitrim
QA Manager
Canada
Canada
Senior Associate QC
Dublin
Dublin
Injection Molding Engineer
North Leinster
North Leinster
Process Development Engineer
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Senior Quality Engineer
Leitrim
Leitrim
Process Engineer (NPI)
Carlow
Carlow
CTO
Dublin
Dublin
Principal Device Engineer
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Operations Engineer
Galway
Galway
Senior Design Engineer
Dublin
Dublin
Principal Engineer
Dublin
Dublin
Compliance Specialist
Carlow
Carlow
Quality Engineer
Galway
Galway
QC Bioanalytical Analyst
Dublin North
Dublin North
R&D Engineer
Galway
Galway
QC Laboratory Technician
Carlow
Carlow
Project Manager - R&D
Galway
Galway
Principal Equipment Engineer
Dublin
Dublin
R&D Manager
Connaught
Connaught
Maintenance Technician
Kilkenny
Kilkenny
Product Development Engineer
Dublin
Dublin
Material Handler
Carlow
Carlow
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Quality Specialist
Clare
Clare
R&D Director
Galway
Galway
Maintenance Technician
Carlow
Carlow
R&D Technician II
Galway
Galway
QC Systems Specialist
Dublin
Dublin
R&D Lifecycle Manager
Connaught
Connaught
R&D Manager
Galway
Galway
Strategic Automation Lead
Waterford
Waterford
Quality Engineer
Galway
Galway
Senior Manager Bioanalytical QC Lab
Limerick
Limerick
Quality Engineer
Galway
Galway
Senior Validation Engineer
Carlow
Carlow
Quality Systems Specialist
Tipperary
Tipperary
Production Operator
Meath
Meath
R&D Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
R&D Engineer
Galway
Galway
NPI Process Engineer
Carlow
Carlow
Senior Mechanical Engineer
Dublin
Dublin
R&D Manager
Athlone
Athlone
Senior Project Engineer
Cavan
Cavan
Principal Engineer
Dublin
Dublin
Senior Design Assurance Engineer
Athlone
Athlone
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Galway
Galway
Process Support Specialist
Carlow
Carlow
R&D Manager
Connaught
Connaught
Utilities Engineer - Black Utilities
Roscommon
Roscommon
Chief Medical Officer
Dublin
Dublin
Senior Project Engineer
Cavan
Cavan
Quality Operations Manager
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Electronic Engineer
Dublin
Dublin
Electronic Engineering
Dublin
Dublin
Production Operator
Carlow
Carlow
R&D Manager
Connaught
Connaught
Quality Specialist & Deputy RP
Limerick
Limerick
R&D Formulation Chemist
Dublin
Dublin
Associate R&D Engineer
Galway
Galway
Senior Validation Engineer
Dublin
Dublin
Operations Manager
Galway
Galway
Production Operator
Meath
Meath
Applications Scientist
Dublin
Dublin
Product Development Engineer
Dublin
Dublin
Production Operator
Carlow
Carlow
Scientist (hybrid)
Meath
Meath
Electronic Engineer
Dublin
Dublin
R&D Engineer
Galway
Galway
Senior Quality Engineer
Galway
Galway
Senior Quality Control Associate
Dublin South
Dublin South
Product Development Engineer
Galway
Galway
Principal Quality Engineer
Galway
Galway
Change Control SME
Cork
Cork
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Manufacturing Engineer
Wexford
Wexford
Senior R&D Engineer
Dublin
Dublin
Quality Control Technician
Carlow
Carlow
Biomedical Engineer
Dublin
Dublin
Production Operator
Dublin
Dublin
Senior Electrical Engineer
Galway
Galway
R&D Program Manager
Dublin
Dublin
Manufacturing Technician
Clare
Clare
R&D Director
Galway
Galway
Senior Process Engineer
Dublin
Dublin
Responsible Person (RP)
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Senior Operations Engineer
Galway
Galway
Senior Electronics Engineer
Dublin
Dublin
Maintenance Reliability Engineer
Tipperary
Tipperary
Associate R&D Engineer
Galway
Galway
Principal Engineer - R&D
Galway
Galway
Quality Control NPI Senior Associate
Dublin South
Dublin South
Project Engineer
Roscommon
Roscommon
R&D Engineer
Galway
Galway
Quality Engineer
Wexford
Wexford
Production Operator
Meath
Meath
EHS Specialist
Meath
Meath
R&D Engineer
Clare
Clare
R&D Manager
Galway
Galway
Quality Specialist
Tipperary
Tipperary
Senior R&D Engineer
Galway
Galway
Quality Specialist
Clare
Clare
Senior R&D Manager/Director
Dublin
Dublin
Engineering Shift Technician
Dublin
Dublin
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
Medical Writer
Cork
Cork
MS&T Associate Director
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
R&D Engineer
Galway
Galway
R&D Engineer
Galway
Galway
Embedded Software Engineer
Dublin
Dublin
Product Development Manager
Galway
Galway
Electronic Engineer
Dublin
Dublin
Principal Equipment Engineer
Dublin
Dublin
QA Validation Specialist
Meath
Meath
Senior R&D Engineer
Galway
Galway
Operations Engineer
Galway
Galway
Manufacturing Technician
Clare
Clare
Principal Engineer
Dublin
Dublin
R&D Manager
Galway
Galway
Injection Moulding Engineer
Leitrim
Leitrim
Injection Moulding Engineer
Athlone
Athlone
VP of Operations
Dublin
Dublin
Project Manager - R&D
Galway
Galway
Quality Technician
Dublin
Dublin
Production Operator
Meath
Meath
Senior R&D Engineer
Clare
Clare
Principal Software Engineer
Athlone
Athlone
Process Engineer (NPI)
Carlow
Carlow
Quality Engineer
Athlone
Athlone
Principal R&D Engineer
Dublin
Dublin
Electronic Engineer
Dublin
Dublin
Validation Engineer
Athlone
Athlone
Quality Director
Galway
Galway
Electronic Design Engineer
Galway
Galway
Product Development Engineer
Galway
Galway
Project Manager
Galway
Galway
Manufacturing Technician
Clare
Clare
R&D Manager
Connaught
Connaught
Senior Operations Engineer
Galway
Galway
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]
Laboratory Scientist Allied Healthcare Supply Chain Supply Chain Cork Cork City Connected Health Scientific Diagnostics Limerick Biotechnology Project Manager Microbiology Mayo Dublin Manufacturing Executive IT Medical Device Product Development Engineer Biopharmaceutical Quality Engineering Pharma Sales Academic Clinical Research Academic Pharmaceutical Quality Control Sales and Marketing Chemistry Sales and Marketing Quality Assurance Medical Affairs Packaging Engineer PhD Validation Engineer Engineering Life Science Scientist
Group sites:
Medical Affairs Jobs | Science Jobs | Scientific Jobs | Connected Health Jobs | Contract Jobs | Clinical Research Jobs | Medical Device Jobs | Pharmaceutical Jobs | Biotechnology Jobs | Quality Assurance Jobs | Engineering Jobs | Supply Chain Jobs | Biopharmaceutical Jobs | Chemistry 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






