I'm looking for...
close

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.

crome
Google Chrome		 IE
Internet Explorer		 firefox
Mozilla Firefox		 opera
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
James Cassidy
Life Science

+353 1 5079250
[email protected]
Connect with me on
Hot Science Jobs
R&D Manager
Connaught
Maintenance & Reliability Technician
Limerick
Senior Engineering Manager
Limerick
Design Assurance Engineer
Clare
Sr Electrical Engineer
Galway
Project Manager Design Assurance
Galway
Senior Maintenance Technician
Kilkenny
Process Engineer
Carlow
Associate Director - Manufacturing &
Limerick
R&D Manager
Connaught
Process Engineer
Roscommon
Utilities Engineer
Dublin
R&D Manager
Galway
Manufacturing Technician
Clare
Engineering Shift Technician
Dublin
Manufacturing Technician
Galway
Maintenance Manufacturing Technician
Kilkenny
Principal Device Engineer
Dublin
Advanced Technologies R&D Manager
Clare
Senior Electronic Engineer
Dublin
Project Manager - R&D
Galway
Territory Manager (Woundcare)
Cork
R&D Manager
Galway
R&D Engineer
Dublin
Quality Specialist
Clare
Electronic Engineering
Dublin
R&D Manager
Connaught
Quality Engineer
Athlone
R&D Director
Galway
R&D Engineer
Galway
Quality Specialist
Tipperary
Product Development Engineer
Galway
R&D Engineer
Galway
Electrical Condition Monitoring Technici
Limerick
Senior Design Assurance Engineer
Galway
QA Manager
Canada
R&D Manager
Galway
Staff R&D Engineer
Limerick
R&D Director
Galway
R&D Director
Galway
Manufacturing Engineer
Galway
Senior R&D Engineer
Clare
Advanced Technologies Manager
Galway
R&D Engineer
Galway
Technical Life Cycle & Engineering M
Galway
Manufacturing Technician
Clare
Principal Instrumentation & Calibrat
Limerick
Manufacturing Engineer
Cork
CTO
Dublin
Documentation Specialist
Louth
Product Development Engineer II
Athlone
Quality Assurance Specialist (Logistics)
Dublin
Director Engineering & Supply Chain
Galway
Senior R&D Engineer-New Product Deve
Westmeath
Maintenance & Reliability Technician
Limerick
Product Development Engineer
Dublin
CTO
Galway
Senior Maintenance Technician
Roscommon
Quality Engineer
Wexford
Process Engineer
Roscommon
Manufacturing Technician
Clare
Health & Safety Specialist
Dublin
Product Development Engineer II
Athlone
Senior R&D Manager - Lifecycle Manag
Galway
Senior R&D Engineer
Galway
Quality Manager
Galway
(Senior) Manufacturing Engineers - Globa
Limerick
Quality Engineer
Athlone
R&D Manager
Athlone
Senior Regulatroy Affairs Specialsit
Galway
Senior R&D Engineer
Dublin
Senior R&D Engineer
Galway
Strategic Automation Lead
Waterford
Project Manager (hybrid)
Dublin
Process Development Engineer
Galway
Associate Analytical Scientist
Meath
Product Development Engineer
Galway
R&D Engineer
Dublin
Project Manager
Kildare
Senior Quality Engineer
Galway
Principal Quality Engineer
Galway
Senior Operations Engineer
Galway
Principal R&D Engineer
Galway City
Project Engineer
Louth
Biomedical Engineer
Dublin
Senior Electronic Engineer
Dublin
Clinical Research Associate
Cork
R&D Manager
Galway
Senior Maintenance Technician
Kilkenny
Quality Engineer
Galway
Principal R&D Engineer
Dublin
Engineering Support Specialist
Louth
Operational Excellence Specialist
Cork
Growth Manager (Healthcare)
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Senior Quality Engineer
Dublin
Product Development Engineer II
Athlone
Documentation Specialist
Louth
Senior Quality Systems Engineer
Galway
Quality Operations Manager
Dublin
Senior Product Development Engineer
Galway
Quality Assurance Team Lead
Cork
Senior Reg Affairs Specialist - Post Mar
Galway
Quality Manager
Dublin
R&D Engineer
Galway
Senior R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Dublin
Senior Process Engineer
Carlow
Process Engineer
Dublin
Senior R&D Engineer
Galway
Quality Control Analyst (shift)
Carlow
Quality Manager - Medical Devices
Limerick City
Product Development Manager
Galway
Senior Project Engineer
Cavan
Design Assurance Program Manager
Galway
Senior Quality Engineer
Dublin
Senior R&D Engineer
Dublin
R&D Project Manager
Galway
R&D Engineer
Clare
Manufacturing Project Engineer
Mayo
Maintenance Technician
Kilkenny
Principal Engineer
Dublin
R&D Director
Galway
Principal R&D Engineer
Galway
Senior Equipment Design Engineer
Dublin
R&D Engineer
Galway
Learning Systems Lead
Limerick
Project Engineer - Senior
Cavan
Project Engineer
Roscommon
Principal Reliability Engineer
Galway
R&D Manager
Connaught
R&D Manager
Galway
Responsible Person (RP)
Republic of Ireland
Electronic Engineer
Dublin
Software Design Assurance Engineer
Dublin
Regulatory Affairs Associate
Cork
Senior Quality Engineer
Leitrim
Embedded Software Engineer
Dublin
Senior Equipment Design Engineer
Dublin
Mechanical Technician
Carlow
Maintenance CMMS Engineer
Tipperary
Senior R&D Engineer
Galway
Senior Quality Engineer
Dublin
Biomedical Engineer
Dublin
EHS Officer
Dublin
Senior Technical Transfer Specialist
Cork
Senior R&D Manager - Lifecycle Manag
Galway
Application Software Engineer
Galway
R&D Manager
Dublin
Principal R&D Engineer
Galway
Engineering Business Manager
Dublin
Design Quality Engineer
Galway
Design Assurance Engineer
Galway
R&D Engineer
Galway
Senior Operations Engineer
Galway
Purchasing & Planning Manager
Wexford
Senior R&D Manager
Athlone
R&D Engineer
Galway
Clinical Research Associate
Cork
Quality Systems Manager
Dublin
Injection Moulding Engineer
Leitrim
Senior Electronic Engineer - Regulated M
Galway
Senior Principal Design and Development
Galway
Quality Engineer
Galway
Reliability Engineering Consultant - Rem
Republic of Ireland
Change Control SME
Cork
Documentation Specialist
Louth
Project Manager - R&D
Galway
Senior R&D Engineer
Galway
Senior Design Engineer
Dublin
Project Engineer
Clare
Senior Regulatory Affairs Specialist
Clare
Senior Quality Control Associate
Dublin South
Project Manager - R&D
Galway
Electronic Engineer
Dublin
Senior Project Engineer
Cavan
Validation & Verification Engineer
Dublin
Product Development Engineer
Dublin
Sr Electrical Engineer
Galway
Product Development Engineer
Dublin
Senior / Lead Electrical Engineer
Limerick
QA Engineer
Leitrim
R&D Engineer
Galway
R&D Engineer
Galway
Senior Process Development Engineer
Galway
Senior R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Clinical Research Manager
Cork
Quality Engineer
Galway
Senior Manufacting Engineer
Republic of Ireland
Senior R&D Engineer
Galway
R&D Lifecycle Manager
Connaught
Electronic Engineer
Dublin
R&D Manager
Athlone
Senior Maintenance Technician
Kilkenny
R&D Engineer
Galway
Senior Quality Engineer
Dublin
Injection Molding Engineer
North Leinster
Product Development Engineer
Dublin
Process Chemist
Limerick
Quality Engineer
Galway
Project Engineer
Limerick
Senior Design Engineer
Dublin
Senior Quality Assurance Specialist (hyb
Dublin
Product Development Engineer
Dublin
Manufacturing Engineer
Galway
Calibration Technician
Republic of Ireland
Senior Recruitment Consultant
Republic of Ireland
Design Assurance Program Manager
Galway
R&D Scientist (Microbiology)
Wexford
Product Development Engineer
Dublin
Senior Validation Engineer
Louth
Buyer / Planner
Sligo
Senior Associate Quality Control
Dublin
Senior R&D Engineer
Galway
Principal Engineer
Dublin
Quality Specialist
Clare
Sr Electrical Engineer
Galway
Mechanical Engineer
Dublin
Senior Mechanical Engineer
Dublin
Quality Specialist
Clare
Validation Engineer
Athlone
Quality Assurance Senior Specialist
Louth
Senior Recruitment Consultant
Republic of Ireland
Senior Equipment Design Engineer
Dublin
Project Manager
Kildare
Warehouse Operator
Meath
Senior Manufacturing Engineer
Galway
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to [email protected]
Details

Senior Regulatory Affairs Specialist


Reference:JCAO1229 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: 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