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
Product Development Engineer II
Athlone
R&D Engineer
Clare
Supply Chain Specialist - New Material I
Meath
Senior Regulatory Affairs Specialist
Athlone
Product Specialist (Critical Care &
Dublin
Manufacturing Technician
Clare
Quality Manager
Dublin
Tech Transfer Lead
Dublin
Senior Project Engineer - R&D
Galway
Senior Regulatory Affairs
Galway
QA Manager
Canada
Quality Engineer
Galway
Senior QA Specialist
Dublin
Purchasing & Planning Manager
Wexford
Product Development Engineer
Galway
Senior QC Associate (Bioassay)
Dublin
Design Assurance Program Manager
Galway
Equipment Engineer (Syringe filling)
Dublin
Biomedical Engineer
Dublin
Principal R&D Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Principal R&D Engineer
Galway
Senior Quality Engineer
Dublin
Advanced Technologies Manager
Galway
Senior R&D Engineer
Galway
R&D Manager
Connaught
Senior Quality Engineer
Leitrim
Project Manager
Kildare
Quality Specialist
Tipperary
R&D Senior Program Manager
Galway
R&D Manager
Galway
R&D Technician II
Galway
Senior Product Development Engineer
Galway
Senior Manufacturing Engineer
Galway City
Regulatory Affairs Specialist
Cork
Sr Project Manager - Syringe Fill Engine
Dublin
Process Engineer
Leitrim
Senior Regulatory Affairs Specialist
Dublin
R&D Manager
Dublin
Senior Research and Development Engineer
Galway
Product Development Manager
Galway
Design Assurance Engineer
Galway
Manufacturing Technician
Galway
Senior R&D Engineer
Dublin
Senior Quality Systems Engineer
Galway
Quality Manager
Galway
R&D Manager
Connaught
Principal R&D Engineer
Dublin
Mechanical Technician
Carlow
Senior Electronic Engineer
Dublin
Documentation Specialist
Louth
Senior Project Engineer
Cavan
R&D Manager
Galway
Quality Manager
Galway
Senior Regulatory Affairs Specialist
Athlone
Software Design Assurance Engineer
Dublin
Administrative Assistant
Tipperary
Sales Specialist (Life Sciences)
Dublin
Senior Equipment Design Engineer
Dublin
Product Development Engineer
Galway
Quality Assurance Specialist (shift)
Carlow
Senior Quality Engineer
Dublin
Business Development Manager
Republic of Ireland
Process Engineer
Galway
R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Clare
R&D Lifecycle Manager
Connaught
R&D Manager
Galway
Quality Engineer - Supplier
Galway
Engineering Shift Technician
Dublin
Senior Design Assurance Engineer
Galway
Quality Assurance Specialist
Carlow
Technical Life Cycle & Engineering M
Galway
Senior R&D Engineer-New Product Deve
Westmeath
Senior Quality Assurance Associate
Dublin
Regulatory Affairs Maanger
Galway
Director of R&D
Limerick
Director of Regulatory Affairs
Galway
Regulatory Affairs Manager - Senior
Galway
Quality Manager
Galway
Supplier Quality Engineer
Galway
Senior QC Associate - Equipment & I
Dublin
Senior Maintenance Technician
Kilkenny
Responsible Person (RP)
Republic of Ireland
Quality Technician
Dublin
Shift Technician (Injection Moulding)
Kildare
Technical Life Cycle & Engineering M
Galway
Product Development Manager
Galway
Principal Design Assurance Engineer
Galway
Senior QC Bioassay Associate
Dublin
Supply Chain Project Manager (hybrid)
Dublin
Quality Assurance Specialist (hybrid)
Dublin
Quality Assurance Associate
Cork
R&D Director
Galway
Project Engineer
Clare
EHS Specialist II
Limerick
Senior Maintenance Technician
Kilkenny
CTO
Galway
Principal R&D Engineer
Galway
Senior R&D Engineer
Dublin
Project Manager
Galway
Senior Product Development Engineer
Galway
Principal Design and Development Enginee
Galway
R&D Engineer
Galway
Senior QA Associate (shift)
Dublin
Documentation Specialist
Louth
R&D Engineer
Galway
Quality Manager - NPI
Dublin
Senior Regulatory Affairs Specialist
Athlone
LIMS Specialist
Tipperary
Strategy Associate Director / Director -
Dublin
Learning Systems Lead
Limerick
Quality Engineer
Athlone
Key Account Manager - Retail UK National
South East
Senior Electronic Engineer - Regulated M
Galway
Senior Regulatory Affairs Specialist
Athlone
Senior Manufacting Engineer
Republic of Ireland
Senior Quality Assurance Engineer
Galway
R&D Engineer
Galway
Senior Project Engineer
Cavan
A.I Specialist
Clare
Senior Engineering Manager
Galway
Product Specialist (Critical Care &
Dublin
Senior Research & Development Engine
Limerick
Senior Maintenance Technician
Roscommon
Quality Specialist
Clare
Quality Assurance Team Lead
Cork
Manufacturing Engineer
Galway
Senior Quality Control Associate
Dublin South
Senior Electrical Engineer
Galway
Senior Process Engineer - DP or DS
Dublin
R&D Engineer
Galway
Quality Technician
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Senior Regulatory Affairs Manager
Galway
Senior R&D Engineer
Galway
R&D Manager
Galway
Sales Manager (Healthcare)
Dublin
Senior Equipment Design Engineer
Dublin
Senior Process Engineer
Dublin
Tech Transfer Lead - Sterile Drug Produc
Dublin
Quality Manager
Galway
Process Development Engineer
Galway
Principal R&D Engineer
Dublin
Biomedical Engineer
Dublin
Product Specialist - Orthopaedic Divisio
Dublin
R&D Engineer
Galway
Senior Design Assurance Engineer
Galway
Business Resilience Specialist
Dublin
Senior Technology Transfer Specialist
Dublin
Senior Reg Affairs Specialist - Post Mar
Galway
Senior R&D Engineer
Galway
Product Development Engineer
Dublin
Quality Specialist
Clare
Validation Engineer
Athlone
Quality Engineer - Supplier
Galway
R&D Engineer
Galway
Quality Assurance Specialist (Logistics)
Dublin
Senior QC Microbiology
Dublin
Senior Maintenance Technician
Kilkenny
Sales/Customer Service Administrator
Clonmel
R&D Manager
Athlone
Lead MSAT Validation Consultant
Republic of Ireland
R&D Manager
Athlone
Manufacturing Specialist (Investigation
Dublin
R&D Engineer
Galway
Senior Operational Readiness Associate
Dublin
Senior Quality Engineer
Dublin
Senior Product Development Engineer
Galway
Asbestos Analyst
Down
Project Manager - R&D
Galway
R&D Director
Galway
R&D Manager
Connaught
CTO
Dublin
Quality Engineer - Supplier
Galway
Electronic Engineering
Dublin
Application Software Engineer
Galway
Senior Regulatory Specialist
Cork
Senior Clinical Data Analyst
Dublin
Senior Design Engineer
Dublin
R&D Manager
Galway
Senior Operations Engineer
Galway
Senior Technician Quality Control
Carlow
QA Engineer
Leitrim
Design Quality Engineer
Galway
Staff R&D Engineer
Limerick
Graduate Occupational Hygiene Consultant
Kildare
R&D Engineer
Galway
Senior Project Manager
Meath
Industrial Engineer Capacity Planning
Dublin
R&D Engineer
Dublin
Calibration Technician
Republic of Ireland
Sr Principal R&D Engineer
Galway
Senior Quality Assurance Specialist (hyb
Dublin
Senior QC Microbiology
Dublin
Project Manager
Kildare
R&D Engineer
Dublin
Project Engineer - Senior
Cavan
Senior R&D Manager - Lifecycle Manag
Galway
R&D Director
Galway
Engineering Business Manager
Dublin
Senior Process Engineer - Packaging
Dublin
Senior Audit & Compliance Specialist
Galway
Process Chemist
Limerick
Design Assurance Engineer
Galway
Principal Engineer
Dublin
R&D Manager
Connaught
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