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
Principal Engineer
Dublin
Principal Process Equipment Engineer
Dublin South
Project Manager
Limerick
Cleaning Validation Specialist
Carlow
Warehouse Manager
Dublin
Senior Project Equipment Engineer
Dublin
Senior Project Manager - Process Develop
Dublin
Project Enginer
Dublin South
Process Validation Engineer
Cork
Software Design Assurance Engineer
Dublin
Commisioning and Qualification Engineer
Cork
Quality Manager
Dublin
Quality Engineer
Athlone
R&D Engineer
Galway
Quality Specialist
Clare
Responsible Person (RP)
Republic of Ireland
Senior Electrical Engineer
Galway
Reliability Engineering Specialist
Louth
Clean Utilities Engineer
Carlow
Product Development Engineer
Dublin
Program Manager
Cork
Quality Specialist - Remediation
Louth
Senoior Specialist - MS&T
Dublin
Manufacturing Engineer
Limerick
Senior Human Factors Engineer
Dublin
R&D Engineer
Dublin
R&D Manager
Galway
Clean Utilities Engineer
Carlow
Electrical Engineer
Cork
Senior Maintenance Technician
Carlow
Project Engineer
Tipperary
Aseptic Process Lead
Carlow
Senior R&D Engineer
Dublin
Process Engineer
Cork
Technical Life Cycle & Engineering M
Galway
Principal Heart Valves Engineer
Galway
Injection Molding Engineer
North Leinster
R&D Manager
Connaught
R&D Manager
Galway
Senior Recruitment Consultant
Dublin
Facilities Engineer
Carlow
Process Chemist
Limerick
Senior Associate Quality Control NPI
Dublin
Principal Engineer
Dublin
Sourcing Specialist
Tipperary
Technical Specialist - Manufacturing Pro
Cork
Technology Transfer Specialist
Cork
QC Laboratory Technician
Carlow
Senior Operations Engineer
Galway
R&D Engineer
Galway
R&D Engineer
Galway
Senior R&D Manager/Director
Dublin
Principal R&D Engineer
Dublin
Associate QA Specialist (Shift)
Carlow
QA Manager
Canada
Product Development Manager
Galway
C&Q Lead
Tipperary
Validation Specialist
Cork
QA Associate Specialist - Shift
Carlow
Recruitment Consultant
Republic of Ireland
R&D Engineer
Galway
Packaging Engineer
Dublin
Senior Regulatory Affairs Specialist
Dublin
Senior Regulatroy Affairs Specialsit
Galway
Quality Engineer
Athlone
Buyer
Wexford
Senior Manufacting Engineer
Republic of Ireland
Clinical Project Manager
Cork
Production Operator
Dublin
QA Manager
Canada
Quality Specialist
Clare
Senior Associate Quality Control
Dublin
Process Engineer
Limerick
Quality Technician
Dublin
Senior Regulatory Affairs Specialist
Clare
Project Manager - R&D
Galway
Senior Product Development Engineer
Galway
R&D Manager
Dublin
Commissioning and Qualification Engineer
Cork
R&D Manager
Galway
Senior Project Engineer - Utilities
Dublin
Senior Validation Engineer
Dublin
Head of R&D
Galway
Senior R&D Engineer
Galway
Process Simulation Technical Engineer
Carlow
Quality Systems Specialist
Galway
Applications Scientist
Dublin
Project Engineer
Clare
Product Lead
Dublin
R&D Engineer
Galway
Account Manager UK and Ireland
Republic of Ireland
Senior Equipment Design Engineer
Dublin
Senior Quality Engineer
Limerick
Quality Engineer
Galway
R&D Director
Galway
Chief Medical Officer
Dublin
R&D Director
Galway
Senior Validation Engineer
Limerick
Lead Maintenance Reliability Engineer
Westmeath
Business Manager (Pharma Chemicals)
Westmeath
Senior Operations Engineer
Galway
Technical Transfer Specialist - Remote
Republic of Ireland
Quality Engineer
Wexford
R&D Manager
Galway
Senior R&D Project Manager
Galway
Senior Project Engineer
Cork
R&D Engineer
Galway
Quality Technician
Dublin
Senior R&D Engineer
Galway
Principal Quality Engineer
Galway
Operations Manager
Wexford
Principal Software Engineer
Athlone
Senior Project Engineer
Cavan
Manufacturing Engineer
Cork
Procurement Senior Specialist
Meath
Principal R&D Engineer
Galway
E&I Turnover Engineer
Carlow
Instrument Specialist
Tipperary
Senior Quality Engineer
Dublin
Quality Technical Services Manager - 12
Dublin
Principal Scientist Global Regulatory Af
Cork
Senior Equipment Design Engineer
Dublin
Operations Specialist
Louth
Quality Engineer
Galway
Senior Validation Engineer
Limerick
Senior Regulatory Affairs
Galway
Remote Process Engineer - Fill Finish
Republic of Ireland
Senior R&D Engineer
Galway
Commissioning and Qualification Engineer
Dublin
Lead Chemistry Analyst
Cork
Senior Design Engineer
Dublin
Maintenance Engineer
Cork
Product Development Engineer
Galway
Engineering Shift Technician
Dublin
Compliance Engineer
Carlow
Quality and Regulatroy Manager
Galway
Process Engineer (Shift)
Carlow
R&D Manager
Connaught
Senior Electronic Engineer
Dublin
Technical Transfer Lead
Dublin
Project Engineer
Limerick
Chemical Engineer
Tipperary
Senior Quality Engineer
Leitrim
Quality Manager - NPI
Dublin
Quality Control NPI Senior Associate
Dublin South
Senior Process Engineer
Cork
Senior Process Development Engineer
Galway
Manufacturing Engineer
Galway
Quality Engineer
Galway
Senior Validation Engineer
Dublin
Senior R&D Engineer
Dublin
Senior Project Manager - Process Develop
Cork
Senior Equipment Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Senior Quality Engineer-Remote
Republic of Ireland
R&D Manager
Athlone
Principal Device Engineer
Dublin
R&D Manager
Athlone
Production Operator
Carlow
Suite Team Delivery Lead
Tipperary
Quality Control Technician
Carlow
Project Manager - R&D
Galway
Engineering Business Manager
Dublin
Project Manager - Capital Projects
Cork
Quality Assurance Engineer
Longford
Product Development Engineer
Galway
Senior Process Engineer
Cork
Senior Regulatory Affairs Specialist
Westmeath
Senior Regulatory Affairs Specialist
Athlone
Senior Quality Engineer
Leitrim
Process Support Specialist
Carlow
Validation Engineer
Carlow
R&D Manager
Connaught
Technical Transfer Specialist - Remote
Republic of Ireland
Senior Technical Scientist - Technical T
Cork
Product Development Engineer II
Athlone
R&D Engineer
Galway
R&D Program Manager
Dublin
Senior QC Associate
Dublin
Quality Operations Manager
Dublin
QA Engineer
Leitrim
Senior R&D Manager
Athlone
Validation Engineer
Athlone
Senior Associate QC
Dublin
Principal Process Development Engineer
Dublin
Senior Clinical Project Manager
Dublin
Advanced Technologies Manager
Galway
Maintenance Planner
Westmeath
Senior Mechanical Engineer
Dublin
Technical Transfer Specialist
Dublin
Senior Recruitment Consultant
Republic of Ireland
Master Data Associate
Limerick
Project Engineer
Cork
CQV Lead
Tipperary
Technical Life Cycle & Engineering M
Galway
Project Engineer - Senior
Cavan
Technical Administrator
Tipperary
Product Development Manager
Galway
Engineering Projects Lead
Carlow
Senior Microbiologist
Republic of Ireland
R&D Director
Galway
Senior Validation Engineer
Dublin
CSV Engineer - IT Labs
Limerick
QC Separation Analyst
Cork
R&D Engineer
Dublin
Process Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Quality Specialist
Tipperary
Quality Control Technician
Carlow
Quality Specialist
Tipperary
Quality Technician
Dublin
Associate Director Global Regulatory Aff
Cork
Material Handler
Carlow
Advanced Technologies Manager
Galway
Cleaning Validation Engineer
Carlow
Senior E&I Maintenance Technician
Carlow
Project Engineer
Republic of Ireland
Senior Recruitment Consultant
Republic of Ireland
R&D Technician II
Galway
Senior R&D Manager
Athlone
R&D Engineer
Clare
Maintenance Technician
Carlow
Senior Quality Engineer
Dublin
R&D Manager
Connaught
Biomedical Engineer
Dublin
Senior Equipment Design Engineer
Dublin
R&D Engineer
Galway
Senior Quality Engineer
Galway
Project Manager - R&D
Galway
Advanced Technologies R&D Manager
Clare
Materials Management Scientist
Limerick
R&D Project Manager
Galway
Senior Regulatory Affairs Specialist
Athlone
Maintenance CMMS Engineer
Tipperary
Injection Moulding Engineer
Athlone
Biostatistician
Dublin City Centre
Embedded Software 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