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
Quality Technician
Galway
Quality Engineer - Supplier
Galway
R&D Engineer
Galway
Product Development Engineer
Galway
Principal R&D Engineer
Galway
Equipment Engineer (Formulation, Autocla
Dublin
Senior Electronic Engineer
Dublin
Senior Research and Development Engineer
Galway
Director of R&D
Galway
Manufacturing Technician
Clare
Senior Quality Assurance Associate
Dublin
Vigilance Assessor
Dublin
Warehouse Operator
Meath
Senior QC Microbiology
Dublin
Project Manager
Kildare
Principal Design Assurance Engineer
Galway
Senior R&D Engineer
Dublin
Quality Specialist
Tipperary
Quality Engineer
Galway
Production Operator
Meath
R&D Manager
Connaught
Quality Engineer
Galway
Senior Research and Development Engineer
Galway
Senior R&D Engineer
Galway
Operations Manager
Galway
Key Account Manager - Retail UK National
South East
Validation Engineer
Republic of Ireland
Principal Engineer
Dublin
Continuous Improvement Coach
Limerick
Quality Manager
Dublin
QA Operations Specialist
Dublin
R&D Manager
Galway
Quality Assurance Team Lead
Cork
R&D Manager
Connaught
Senior Maintenance Technician
Kilkenny
Quality Manager - Medical Devices
Limerick City
R&D Program Manager
Dublin
Senior Design Assurance Engineer
Galway
Site Services Supervisor (Biopharma) - C
Cork
Program Manager (AVI Lines Operational R
Dublin
Engineering Support Specialist
Louth
Sterilisation Manager
Tipperary
Director of R&D
Limerick
Senior Quality Engineer
Leitrim
R&D Manager
Dublin
R&D Director
Galway
R&D Manager
Athlone
Senior Process Development Engineer
Galway
QA Engineer
Leitrim
Senior R&D Engineer
Clare
R&D Manager
Athlone
Project Engineer - Senior
Cavan
Senior R&D Manager - Lifecycle Manag
Galway
Principal R&D Engineer
Dublin
Senior QC Associate (Bioassay)
Dublin
Senior Clean Utilities Engineer
Dublin
Director of Regulatory Affairs
Galway
Injection Moulding Engineer
Athlone
Manufacturing Engineer
Galway
CTO
Dublin
Senior Regulatory Affairs Specialist
Athlone
Senior Research Engineer
Galway
Environmental Health & Safety (EHS)
Longford
Principal Design Assurance Engineer
Galway
Senior Quality Systems Engineer
Galway
Principal R&D Engineer
Galway
Senior R&D Manager
Athlone
Product Specialist (Critical Care &
Dublin
Documentation Specialist
Louth
Documentation Specialist
Louth
NPI Engineer - Hybrid
Dublin
R&D Engineer
Galway
Design Assurance Engineer
Galway
Senior Design Engineer
Dublin
Dental- Manager/ Senior Manager Business
Republic of Ireland
Strategy Associate Director / Director -
Dublin
Senior Equipment Design Engineer
Dublin
Senior Electronics Engineer
Dublin
Calibration Technician
Republic of Ireland
Regulatory Affairs Manager - Senior
Galway
Process Development - Senior Project Man
Dublin
R&D Engineer
Galway
Validation Engineer
Carlow
Senior Regulatory Affairs Specialist
Athlone
Senior Principal R&D Engineer
Galway City
CTO
Galway
Process Chemist
Limerick
Continuous Improvement Coach
Limerick
Senior Research Scientist
Galway
Quality Assurance Specialist (shift)
Carlow
Senior Quality Assurance Specialist
Cork
Senior Operations Engineer
Galway
Senior Equipment Design Engineer
Dublin
Senior Equipment Design Engineer
Dublin
CQV /CSV Quality Assurance Specialist (H
Dublin
Senior Quality Engineer
Galway
Senior Research Scientist
Galway
Senior QC Microbiology
Dublin
R&D Engineer
Clare
QA Manager
Canada
Sales/Customer Service Administrator
Clonmel
Senior R&D Engineer
Dublin
Senior R&D Engineer
Galway
Responsible Person (RP)
Republic of Ireland
Inside Sales Representative (IVD Divisio
Kildare
Director of Regulatory Affairs
Galway
Principal Reliability Engineer
Galway
R&D Engineer
Galway
Purchasing & Planning Manager
Wexford
Quality Assurance Specialist/Manager
Dublin
Accreditation Manager
Republic of Ireland
Product Development Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Senior Project Engineer
Cavan
Regulatory Affairs Specialist
Cork
Senior Design Engineer
Dublin
Senior R&D Engineer
Galway
R&D Manager
Galway
Senior Manufacturing Engineer
Galway
Senior R&D Engineer
Galway
Manufacturing Technician
Galway
R&D Manager
Galway
Senior Product Development Engineer
Galway
Senior Process Development Engineer
Dublin
Senior Regulatory Specialist
Cork
Advanced Technologies R&D Manager
Clare
Senior Design Assurance Engineer
Galway
Product Development Manager
Galway
Senior Quality Engineer
Galway
Business Development Manager
Republic of Ireland
Senior Associate QC (QC Sample Managemen
Dublin
Quality Assurance Specialist (shift)
Carlow
R&D Manager
Connaught
Quality Technician
Galway
R&D Engineer
Galway
Senior R&D Engineer
Dublin
Senior Electronic Engineer
Dublin
Senior Technician Quality Control
Carlow
Senior Electronic Engineer
Dublin
R&D Engineer
Dublin
Senior Quality Engineer
Dublin
Senior Quality Engineer
Leitrim
Manufacturing Technician
Clare
R&D Engineer
Galway
Project Manager
Galway
Sterilisation Manager
Tipperary
Principal Quality Engineer
Galway
Laboratory Technician
Carlow
Senior R&D Engineer
Dublin
Principal Software Engineer
Athlone
Mechanical Engineer
Dublin
Learning Systems Lead
Limerick
Manufacturing Technician
Clare
Senior Quality Assurance Associate
Dublin
Senior Regulatory Affairs Specialist
Athlone
Senior Product Development Engineer
Galway
Senior Scientist
Dublin
Injection Moulding Engineer
Athlone
EHS Specialist II
Limerick
Project Engineer
Cork
Senior R&D Engineer II
Galway
Senior Quality Engineer
Dublin
Quality Technician
Dublin
Senior R&D Engineer
Galway
Project Manager
Kildare
Project Manager (Pharma)
Dublin
Continuous Improvement Coach
Limerick
R&D Manager
Galway
Quality Engineer
Galway
Senior Engineering Manager
Limerick
Senior Quality Engineer
Dublin
R&D Engineer
Galway
Senior Design Assurance Engineer
Athlone
Senior Manufacturing Specialist
Dublin
Senior Quality Systems Engineer
Galway
Senior R&D Engineer
Galway
Senior NPI Engineer - Hybrid
Dublin
Product Development Engineer II
Athlone
Quality Engineer
Galway
R&D Director
Galway
Product Specialist - Orthopaedic Divisio
Dublin
R&D Manager
Connaught
Senior R&D Engineer
Galway
Senior Regulatory Affairs Manager
Galway
Injection Moulding Engineer
Athlone
Commercial Attribute Science Scientist
Dublin
Technical Life Cycle & Engineering M
Galway
Engineering Support Specialist
Louth
Quality Engineer
Galway
Senior R&D Engineer
Galway
Clinical Trial Manager
Republic of Ireland
Quality Assurance Specialist (hybrid)
Dublin
Process Engineer
Galway
Senior Regulatory Affairs Specialist
Clare
Quality Control Analyst (shift)
Carlow
Senior Manufacting Engineer
Republic of Ireland
Supply Chain Project Manager (hybrid)
Dublin
Project Manager (hybrid)
Dublin
R&D Manager
Galway
Associate Quality Specialist
Tipperary
Principal R&D Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
R&D Engineer
Dublin
Principal Design Assurance Engineer
Galway
Shift Technician (Injection Moulding)
Kildare
Quality Technician
Dublin
Warehouse Operator
Meath
Senior Principal Design and Development
Galway
Supplier Quality Engineer
Galway
Senior Process Engineer
Longford
Director of Quality Engineering
Limerick
R&D Director
Galway
Senior Microbiologist
Dublin
Engineering Shift Technician
Dublin
Documentation Specialist
Louth
Senior Reg Affairs Specialist - Post Mar
Galway
R&D Technician
Galway
Senior Quality Control Associate
Dublin South
Senior Project Manager - Fill Finish
Dublin
Senior Equipment Design Engineer
Dublin
Senior R&D Engineer
Galway
Application Software Engineer
Galway
Process Development Engineer
Galway
Product Development Engineer II
Athlone
Quality Specialist
Clare
Senior Maintenance Technician
Kilkenny
Principal Engineer
Dublin
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