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
Senior R&D Engineer
Galway
Quality Engineer
Athlone
Senior Process Development Engineer
Galway
Senior Quality Assurance Associate (REMO
Dublin
Account Manager UK and Ireland
Republic of Ireland
Process Engineer (NPI)
Carlow
QA Manager
Canada
CMC Regulatory Senior Scientist
Cork
Senior R&D Engineer
Galway
Senior Associate Quality Control
Dublin South
Technical Sales Manager (Chemistry)
Westmeath
Senior Electronic Engineer
Dublin
Senior Equipment Design Engineer
Dublin
R&D Engineer
Clare
Principal R&D Engineer
Galway
R&D Program Manager
Dublin
Senior Associate QA (24/7 Shift)
Dublin
CMC Regulatory Principal Scientist
Cork
Medical Device Director
Republic of Ireland
Senior Recruitment Consultant
Republic of Ireland
Injection Molding Engineer
North Leinster
Strategic Automation Lead
Waterford
Principal R&D Engineer
Dublin
Process Engineer
Limerick
Principal Heart Valves Engineer
Galway
R&D Director
Galway
Associate Director Clinical Regulatory S
Cork
Injection Molding Engineer
North Leinster
Principal Scientist Global Regulatory Af
Limerick
Validation Engineer
Athlone
QC Laboratory Technician Shift (Incoming
Carlow
Senior Validation Engineer
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Principal Process Development Engineer
Galway
Senior Electrical Engineer
Galway
Senior R&D Project Manager
Galway
Remote Process Engineer - Fill Finish
Republic of Ireland
Chemical Engineer
Tipperary
Cleaning Validation Specialist
Cork
Validation Engineer
Cork
Lead Project Engineer
Carlow
Associate Global Trade Ops
Dublin
Senior Regulatory Affairs Specialist
Athlone
Senior Quality Control Associate
Dublin South
Project Process Engineer
Carlow
Senior Design Assurance Engineer
Galway
Quality Manager / PRRC
Dublin
Documentation Specialist
Cork
Engineering Business Manager
Dublin
NPI Process Engineer
Carlow
Senior Design Engineer
Dublin
Senior Product Development Engineer
Galway
Project Manager
Limerick
Lead Maintenance Reliability Engineer
Westmeath
Packaging Engineer
Dublin
EHS Specialist
Carlow
Engineering Shift Technician
Dublin
Sr. Associate - Quality for Computer Sys
Cork
Senior Process Engineer
Cork
Associate Quality Specialist
Tipperary
Cleaning Validation Engineer
Denmark
Senior R&D Engineer
Galway
Batch Record Reviewer
Cork
Regulatory Affairs Specialist
Cork
Quality Control Technician
Carlow
Product Lead
Dublin
Process Validation Engineer
Cork
R&D Engineer
Galway
C&Q Lead
Tipperary
Project Engineer
Tipperary
Technical Specialist - Analytical &
Cork
Process Engineer (Shift)
Carlow
Senior R&D Engineer
Clare
Quality Control Analyst
Greece
Project Engineer
Clare
Scientific Technical Specialist
Dublin
Senior Human Factors Engineer
Dublin
Embedded Software Engineer
Dublin
Project Engineer
Limerick
Biostatistician
Dublin City Centre
Business Systems Director
Louth
Project Engineer
Roscommon
Senior Electronic Design Engineer
Dublin
Regional Procurement Senior Specialist (
Dublin
Facilities Engineer
Carlow
Technical Specialist - Process Support
Cork
Senior Electronics Engineer
Dublin
Reliability Engineering Specialist
Louth
R&D Engineer
Galway
Sourcing Specialist
Tipperary
Process Engineer
Cork
Senior Quality Engineer
Galway
R&D Director
Galway
Quality Engineer
Galway
Associate QA Specialist (Shift)
Carlow
R&D Manager
Connaught
Shift Technician (Injection Moulding)
Kildare
QC Separation Analyst
Cork
Senior Reg Affairs Specialist - Post Mar
Galway
Project Engineer - Senior
Cavan
Manufacturing Engineer
Limerick
Technical Marketing Manager
Wexford
Upstream Manufacturing Process Specialis
Cork
CSV Engineer - IT Labs
Limerick
Manufacturing Engineer
Wexford
R&D Engineer
Galway
R&D Engineer
Galway
Product Development Engineer
Dublin
R&D Manager
Galway
MES Engineer
Cork
R&D Manager
Galway
Senior Maintenance Technician
Roscommon
Maintenance Reliability Engineer
Cork
R&D Director
Galway
Senior Equipment Design Engineer
Dublin
Senoior Specialist - MS&T
Dublin
CQV Lead
Tipperary
Senior Recruitment Consultant
Dublin
Manufacturing Technician
Clare
Senior Design Quality Engineer
Dublin
Senior Operations Engineer
Galway
Sr. Associate - Quality for Computer Sys
Limerick
Project Engineer
Republic of Ireland
Senior Quality Engineer
Galway
Senior Quality Engineer-Remote
Republic of Ireland
Electrical Engineer
Limerick
Bioprocess Material Associate - Shift
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Responsible Person (RP)
Republic of Ireland
Senior Regulatory Affairs Specialist
Clare
Suite Team Delivery Lead
Tipperary
Recruitment Consultant
Wexford
R&D Manager
Connaught
Senior R&D Manager - Lifecycle Manag
Galway
Associate Director Clinical Development
Cork
R&D Manager
Galway
Project Manager - Suite Lead
Tipperary
Recruitment Consultant
Republic of Ireland
Project Manager - Capital Projects
Cork
Quality Engineer
Wexford
R&D Engineer
Galway
Validation & Verification Engineer
Dublin
Medical Science Liaison (MSL)
Dublin
Process Development Engineer
Galway
Quality Engineer
Athlone
Cleaning Validation Specialist
Carlow
Technical Transfer Lead
Dublin
Senior Quality Engineer
Dublin
Quality Specialist
Tipperary
R&D Engineer
Dublin
Senior R&D Engineer
Galway
R&D Manager
Connaught
Senior Quality Engineer
Leitrim
Microbiology Manager
Dublin
Technical Specialist - Manufacturing Pro
Cork
Technology Transfer Specialist (Technica
Cork
R&D Director
Galway
Head of R&D
Galway
Operations Specialist
Louth
Compliance Specialist
Carlow
Technical Specialist - Manufacturing Pro
Cork
Senior R&D Engineer
Dublin
Product Development Engineer II
Athlone
R&D Manager
Galway
Principal Software Engineer
Athlone
Senior Design Engineer
Dublin
Senior Electronic Engineer
Dublin
Biostatistician
Dublin City Centre
Injection Moulding Engineer
Athlone
Director of Quality Engineering
Limerick
Senior Equipment Design Engineer
Dublin
Facilities Engineer
Carlow
Senior Manufacting Engineer
Republic of Ireland
Manufacturing Technician
Clare
Product Development Engineer II
Athlone
Product Development Engineer II
Athlone
Commissioning and Qualification Engineer
Cork
R&D Technical Life Cycle & Engin
Galway
R&D Engineer
Clare
Project/Process Engineer - Purification
Cork
Qualified Person
Limerick
Manager R&D
Connaught
Production Operator
Carlow
Senior Associate Quality Control NPI
Dublin
QA Engineer
Leitrim
Senior Process Engineer
Cork
Commissioning and Qualification Engineer
Dublin
Senior R&D Engineer
Dublin
Quality Systems Specialist
Galway
Senior Recruitment Consultant
Republic of Ireland
Senior Validation Engineer
Dublin
Senior Engineering Manager
Limerick
Quality Validation Engineer
Limerick
E&I Turnover Engineer
Carlow
R&D Manager
Connaught
Process Engineer - Water Formulations
Limerick
Manufacturing Engineer
Cork
Senior Manufacturing Manager (hybrid)
Dublin
Senior Electronic Engineer
Dublin
Mechanical Technician - 2 Cycle
Carlow
Principal R&D Engineer
Dublin
Project Enginer
Dublin South
Warehouse Operations Specialist
Louth
Senior Regulatory Affairs Specialist
Athlone
Senior Regulatory Affairs Specialist
Athlone
Principal Process Equipment Engineer
Dublin South
Principal Quality Engineer
Galway
QC Bioanalytical Analyst
Dublin
Senior R&D Manager
Athlone
Project Manager - R&D
Galway
Senior Technical Scientist - Technical T
Cork
R&D Project Manager
Galway
Qualified Person
Limerick
R&D Engineer
Dublin
Senior R&D Manager
Athlone
Quality Control Specialist (hybrid)
Carlow
Global Labelling Technical Regulatory Af
Cork
Quality and Regulatroy Manager
Galway
QA Manager
Canada
Senior HVAC Engineer
Dublin
Senior Equipment Design Engineer
Dublin
Associate Quality Specialist
Cork
Principal/Senior R&D Engineer Cathet
Galway
Senior Technical Transfer Engineer
Cork
Injection Moulding Engineer
Athlone
Senior Project Engineer
Cork
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