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






