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
QA Manager
Canada
Operations Engineer
Galway
Senior Process Engineer
Dublin
Lead Project Engineer
Carlow
QC Laboratory Technician
Carlow
Maintenance CMMS Engineer
Tipperary
Biomedical Engineer
Dublin
Maintenance Reliability Engineer
Tipperary
Process Engineer (NPI)
Carlow
Senior Clinical Project Manager
Dublin
Principal Process Development Engineer
Galway
Product Development Engineer
Dublin
Senior Quality Engineer
Leitrim
R&D Technician II
Galway
R&D Manager
Athlone
Cleaning Validation Specialist
Carlow
Shift Technician (Injection Moulding)
Kildare
Senior Design Engineer
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Production Operator
Meath
R&D Engineer
Galway
R&D Director
Galway
Operations Engineer
Galway
Principal Process Development Engineer
Galway
Manufacturing Biotech Associate 24/7 Shi
Meath
Senior Recruitment Consultant
Republic of Ireland
Head of R&D
Galway
R&D Engineer
Galway
Senior Design Engineer
Dublin
Senior Associate QC
Dublin
Principal R&D Engineer
Galway
Quality Specialist
Tipperary
Quality Technician
Dublin
Project Engineer - Senior
Cavan
Senior Process Development Scientist
Dublin
Senior R&D Engineer
Galway
R&D Director
Galway
R&D Engineer
Galway
Senior Design Assurance Engineer
Athlone
Senior Regulatory Affairs Specialist
Dublin
Project Engineer
Limerick
Biostatistician
Dublin City Centre
Injection Moulding Engineer
Athlone
Validation & Verification Engineer
Dublin
Process Development Engineer
Galway
R&D Manager
Galway
VP of Operations
Dublin
Embedded Software Engineer
Dublin
Senior Project Manager - Process Develop
Cork
Senior Design Assurance Engineer
Galway
Senior Analytical Specialist
Limerick
Design Assurance Program Manager
Galway
Product Development Technician
Galway
Process Support Specialist
Carlow
Product Development Engineer
Dublin
QA Manager
Canada
MS&T Associate Director
Dublin
Manufacturing Engineer
Galway
Quality Engineer
Galway
MS&T Associate Director
Dublin
Regional Program Coordinator - Global Le
Dublin
Senior Quality Engineer
Dublin
Maintenance Technician
Kilkenny
R&D Manager
Connaught
Manufacturing Technician
Clare
Senior Quality Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Senior QC Microbiology (Shift)
Dublin
Senior Equipment Design Engineer
Dublin
Senior Design Assurance Engineer
Galway
R&D Engineer
Galway
R&D Engineer
Galway
Senior Quality Engineer-Remote
Republic of Ireland
Engineering Shift Technician
Dublin
Associate QA Specialist (Shift)
Carlow
Principal Process Development Engineer
Dublin
Senior R&D Engineer
Dublin
Associate R&D Engineer
Galway
R&D Engineer
Galway
R&D Manager
Connaught
Senior QC Microbiology
Dublin
R&D Technician II
Galway
Quality Engineer
Galway
Production Operator
Carlow
R&D Engineer
Clare
Utilities Engineer
Dublin
Responsible Person (RP)
Republic of Ireland
Electronic Engineer
Dublin
Principal Software Engineer
Athlone
Technical Life Cycle & Engineering M
Galway
Principal Preclinical Scientist
Galway
Quality Systems Manager
Dublin
Quality Systems Specialist
Tipperary
R&D Director
Galway
Quality Manager
Galway
Senior Regulatroy Affairs Specialsit
Galway
Principal Equipment Engineer
Dublin
Senior R&D Engineer
Galway
Injection Molding Engineer
North Leinster
Manufacturing Technician
Clare
R&D Manager
Galway
Clean Utilities Engineer
Carlow
Principal Device Engineer
Dublin
Senior Quality Engineer
Leitrim
Principal Scientist Device and Product P
Dublin
R&D Engineer
Galway
Process Engineer (NPI)
Carlow
Electronic Engineer
Dublin
Quality Engineer
Galway
QC Systems Specialist
Dublin
Scientist (hybrid)
Meath
Senior Recruitment Consultant
Republic of Ireland
Product Development Engineer
Galway
Quality Control NPI Senior Associate
Dublin South
Quality Manager - Medical Devices
Limerick City
Process Engineer
Galway
Process Engineer
Cork
Program Manager
Dublin
Quality Manager
Galway
Account Manager UK and Ireland
Republic of Ireland
Quality Operations Manager
Dublin
R&D Engineer
Dublin
Sourcing Specialist
Tipperary
Senior Technical Transfer Specialist
Cork
R&D Manager
Galway
Electronic Engineer
Dublin
Engineering Business Manager
Dublin
Senior Quality Engineer
Dublin
Senior Quality Engineer
Galway
Quality and Regulatroy Manager
Galway
Senior Process Development Engineer
Galway
Utilities Engineer - Black Utilities
Roscommon
R&D Engineer
Galway
R&D Manager
Dublin
Senior Equipment Design Engineer
Dublin
Senior Operations Engineer
Galway
Technology Transfer Specialist
Meath
Operations Excellence Lead
Louth
Senior Tech Transfer Specialist
Meath
QA Engineer
Leitrim
Director of Quality Engineering
Limerick
Principal Equipment Engineer
Dublin
Quality Control Technician
Carlow
Product Development Technician II
Galway
Mechanical Technician - 2 Cycle
Carlow
CTO
Dublin
NPI Process Engineer
Carlow
Quality Technician
Dublin
R&D Engineer
Dublin
Senior QC Associate
Dublin
Senior Technical Transfer Engineer - Hyb
Carlow
Senior Associate Quality Control NPI
Dublin
Senior Manufacturing Engineer
Galway
Product Development Engineer
Dublin
Senior Recruitment Consultant
Dublin
R&D Engineer
Galway
R&D Technician
Galway
Applications Scientist
Dublin
Production Operator
Dublin
Manufacturing Technician
Clare
Quality Control Technician
Carlow
Quality Assurance Engineer
Longford
R&D Engineer
Galway
Project Manager - R&D
Galway
Senior R&D Engineer
Galway
Quality Technician
Dublin
Strategic Automation Lead
Waterford
Senior Regulatory Affairs Specialist
Clare
Senior Regulatory Affairs Specialist
Athlone
Senior R&D Engineer
Galway
Material Handler
Carlow
Manufacturing Engineer
Galway
Clinical Trial Quality Representative
Cork
R&D Manager
Connaught
Quality Specialist & Deputy RP
Limerick
Senior Regulatory Specialist
Cork
Mechanical Design Engineer
Germany
R&D Lifecycle Manager
Connaught
Senior Manufacting Engineer
Republic of Ireland
Senior R&D Engineer
Galway
Maintenance Technician
Carlow
Senior R&D Engineer
Dublin
Quality Engineer
Galway
Product Development Manager
Galway
Associate R&D Engineer
Galway
Manufacturing Technician
Clare
R&D Manager
Connaught
Electronic Engineer
Dublin
Reliability Engineer
Tipperary
Clinical Research Associate
Cork
Senior R&D Engineer
Galway
Senior R&D Engineer
Dublin
Principal Engineer
Dublin
Product Development Engineer
Galway
Quality Engineer
Wexford
Senior Cleaning Validation Engineer
Carlow
Quality Specialist
Clare
Senior Equipment Design Engineer
Dublin
Process Chemist
Limerick
Project Engineer
Clare
Senior Validation Engineer
Dublin
Principal/Senior R&D Engineer Cathet
Galway
Advanced Technologies R&D Manager
Clare
EHS Systems Specialist
Dublin
Principal Quality Engineer
Galway
Senior Engineering Manager
Limerick
Clinical Project Manager
Cork
Senior QC ELN Associate - Electronic Not
Dublin
Senior Regulatory Affairs Specialist
Athlone
Quality Specialist
Tipperary
Injection Molding Engineer
North Leinster
R&D Manager
Galway
Manufacturing Engineer
Cork
Product Development Engineer II
Athlone
R&D Engineer
Galway
Principal R&D Engineer
Dublin
Principal R&D Engineer
Galway
Associate R&D Engineer
Galway
Quality Engineer
Athlone
Senior Project Engineer
Cavan
Senior Quality Engineer
Leitrim
R&D Engineer
Galway
Senior QC Microbiology (24/7 Shift)
Dublin
Senior Operations Engineer
Galway
Clinical Seating Specialist (Dublin)
Dublin
R&D Manager
Athlone
Quality Engineer
Galway
Quality Engineer
Galway
Clinical Research Associate
Cork
Advanced Technologies R&D Manager
Clare
Injection Moulding Engineer
Athlone
Quality Manager
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