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 Equipment Design Engineer
Dublin
R&D Manager
Galway
Senior Electronics Engineer
Dublin
CAPEX API Project Manager
Tipperary
Product Development Manager
Galway
Senior Quality Assurance Technical Suppo
Dublin
Staff Systems Engineer
Limerick
Quality Engineer - Supplier
Galway
Senior QA Associate (shift)
Dublin
Product Specialist (Critical Care &
Dublin
R&D Manager
Galway
Advanced Technologies R&D Manager
Clare
Manufacturing Technician
Clare
Senior R&D Engineer
Galway
Responsible Person (RP)
Republic of Ireland
Principal R&D Engineer
Galway
Quality Assurance Specialist
Waterford
Director Engineering & Supply Chain
Galway
Senior QC Analyst
Republic of Ireland
Principal Software Engineer
Athlone
Director of Regulatory Affairs
Galway
Senior Engineering Manager
Galway
R&D Manager
Galway
Asbestos Analyst
Down
Principal R&D Engineer
Galway
Territory Manager (Endoscopy)
Dublin
R&D Engineer
Galway
Senior Design Assurance Engineer
Galway
Mechanical Technician
Carlow
Senior QC Microbiology
Dublin
Quality Assurance Team Lead
Cork
Quality Manager
Dublin
Manufacturing Specialist - Aseptic Proce
Dublin
Reg Affairs Specialist
Connaught
R&D Manager
Connaught
Quality Manager
Galway
R&D Manager
Connaught
Senior R&D Manager - Lifecycle Manag
Galway
Senior Product Development Engineer
Galway
Quality Technician
Dublin
Lead MSAT Validation Consultant
Republic of Ireland
R&D Technician II
Galway
Quality Assurance Specialist
Carlow
Strategic Automation Lead
Waterford
R&D Manager
Athlone
Senior R&D Engineer
Dublin
Quality Engineer - Supplier
Galway
Senior Quality Control Associate
Dublin South
Senior R&D Engineer
Galway
Supplier Quality Engineer
Galway
Senior Research & Development Engine
Limerick
Quality Technician
Dublin
Senior Quality Engineer
Dublin
Senior Quality Engineer
Dublin
Director of R&D
Galway
Senior Production Manager
Cork
R&D Engineer
Clare
Manufacturing Technician
Clare
Design Assurance Manager
Galway
Quality Manager
Galway
Quality Specialist
Clare
Senior R&D Engineer
Galway
Sales Manager (Healthcare)
Dublin
Senior Quality Engineer
Leitrim
Calibration Technician
Republic of Ireland
Senior Project Design Engineer
Limerick
Project Manager
Kildare
Engineering Shift Technician
Dublin
Process Development - Senior Project Man
Dublin
Senior Specialist MS&T
Dublin
Senior Product Development Engineer
Galway
Sr Project Manager - Syringe Fill Engine
Dublin
Quality Manager
Galway
Senior R&D Engineer
Galway
Principal Quality Engineer
Galway
Quality and Regulatory Affairs Manager
Dublin
Quality Manager
Galway
Project Engineer
Clare
Senior Clinical Data Analyst
Dublin
Senior NPI Engineer - Hybrid
Dublin
R&D Manager
Galway
Shift Technician (Injection Moulding)
Kildare
Regulatory Affairs Maanger
Galway
QA Deviations Specialist
Dublin
Validation Engineer
Carlow
Senior Equipment Design Engineer
Dublin
Manufacturing Specialist - Investigation
Dublin
R&D Engineer
Galway
Senior Process Development Engineer
Galway
Principal Engineer
Dublin
Biomedical Engineer
Dublin
Product Specialist (Critical Care &
Dublin
A.I Specialist
Clare
Quality Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Quality System & Regulatory Affairs
Galway
Senior Quality Assurance Associate
Dublin
QA Manager
Canada
Senior Commissioning & Qualification
Roscommon
Senior Scientist IVD Assay Development
Galway
Quality Manager
Galway
EHSS Specialist
Athlone
Documentation Specialist
Louth
Principal Device Engineer
Dublin
Clinical Trial Protocol Specialist
Galway
Environmental Health & Safety (EHS)
Longford
Laboratory Systems Specialist
Meath
Advanced Technologies R&D Manager
Clare
Senior Regulatory Affairs Manager
Galway
Senior Regulatory Affairs Specialist
Clare
R&D Engineer
Galway
Quality Manager - NPI
Dublin
Injection Molding Engineer
Mayo
Quality Assurance Specialist (hybrid)
Dublin
Senior Quality Engineer
Galway
Process Development Engineer
Galway
R&D Manager
Galway
Director of Quality Engineering
Limerick
Quality Assurance Specialist
Carlow
Senior Regulatory Specialist
Cork
Quality Specialist
Clare
Graduate Occupational Hygiene Consultant
Kildare
Senior Electronic Engineer
Dublin
Senior Supply Chain Manager - Supplier E
Dublin
Product Development Technician II
Galway
R&D Technician II
Galway
Production Manager
Dublin
Quality Assurance Senior Specialist
Louth
Manufacturing Technician
Galway
Director of R&D
Limerick
QC Microbiology Analyst
Dublin
Product Development Engineer II
Athlone
Product Development Engineer
Galway
Quality Assurance Specialist (shift)
Carlow
LIMS Specialist
Tipperary
Senior R&D Engineer
Galway
R&D Director
Galway
Senior Operational Readiness Associate
Dublin
R&D Lifecycle Manager
Connaught
R&D Manager
Athlone
Quality Assurance Specialist/Manager
Dublin
Product Development Engineer
Dublin
Senior Quality Engineer
Galway
Senior Manufacturing Engineer
Galway City
Design Assurance Engineer
Galway
Manufacturing Specialist (Investigation
Dublin
Senior Project Manager - Contract Develo
Dublin
Senior Maintenance Technician
Roscommon
Business Development Manager
Republic of Ireland
Business Development Manager (Hospitals)
Cork
R&D Engineer
Galway
Senior Quality Engineer
Dublin
Senior Design Assurance Engineer
Galway
Analytical Chemist
Tipperary
Quality Specialist
Clare
R&D Engineer
Galway
Manufacturing Technician
Clare
Injection Moulding Engineer
Athlone
R&D Manager
Connaught
Industrial Engineer Capacity Planning
Dublin
Advanced Technologies Manager
Galway
A.I Specialist
Clare
R&D Engineer
Galway
Supply Chain Specialist - New Material I
Meath
Quality Manager
Galway
Senior Quality Systems Engineer
Galway
R&D Engineer
Dublin
Process Chemist
Limerick
Equipment Engineer Intermediate
Dublin
Senior Design Engineer
Dublin
QA Engineer
Leitrim
Senior QA Specialist
Dublin
Project Engineer
Cork
R&D Engineer
Galway
Validation Engineer Intermediate
Dublin
Regulatory Affairs Specialist
Cork
Documentation Specialist
Louth
R&D Manager
Dublin
Quality Control Analyst (Cell Culture)
Carlow
Production Operator
Meath
Senior QC Specialist
Dublin
Process Scientist MSAT
Louth
Principal R&D Engineer
Dublin
Senior Regulatory Affairs Specialist
Westmeath
Quality Control (QC) Technician
Kildare
Principal Engineer
Dublin
QC Specialist
Clare
Project Engineer
Roscommon
R&D Director
Galway
Product Development Engineer II
Athlone
Quality Engineer
Athlone
Senior Quality Engineer
Leitrim
Senior Engineering Manager
Limerick
Senior Project Engineer
Cavan
Senior Maintenance Technician
Kilkenny
Injection Moulding Engineer
Leitrim
CTO
Dublin
R&D Engineer
Dublin
R&D Engineer
Galway
Senior Research and Development Engineer
Galway
Senior Quality Assurance Specialist
Cork
Clinical Trial Protocol Specialist
Galway
Principal Reliability Engineer
Galway
Senior R&D Manager
Athlone
Senior Quality Assurance Specialist (hyb
Dublin
Construction Manager - Pharma/Biotech
Dublin
Product Development Engineer
Galway
Senior R&D Engineer II
Galway
Clinical Sales Specialist (Histology)
Dublin
Sr Electrical Engineer
Galway
NPI Engineer - Hybrid
Dublin
Senior Microbiologist
Dublin
R&D Engineer
Galway
Project Manager - R&D
Galway
Senior R&D Engineer
Galway
Senior Scientific Officer
Dublin
Senior Operations Engineer
Galway
Validation & Verification Engineer
Dublin
Electronic Engineering
Dublin
Project Manager
Kildare
Quality Manager
Galway
CTO
Galway
Operations Lead
Dublin
Senior Quality Engineer
Leitrim
Quality Assurance Associate
Cork
Senior R&D Engineer
Clare
Design Assurance Program Manager
Galway
R&D Director
Galway
Senior Design Assurance Engineer
Galway
Quality Assurance Engineer
Longford
Senior R&D Engineer
Dublin
R&D Engineer
Galway
Senior QC Specialist - Equipment & I
Dublin
Quality Specialist
Tipperary
Principal Design and Development Enginee
Galway
CQV Engineer
Roscommon
Senior Mechanical Engineer
Dublin
Quality Assurance Team Lead
Cork
Senior Operational Readiness Associate
Dublin
R&D Manager
Connaught
Senior Design Assurance Engineer
Galway
Electrical Condition Monitoring Technici
Limerick
Project Manager - New Product Introducti
Dublin
Senior Regulatory Affairs Specialist
Athlone
Sales/Customer Service Administrator
Clonmel
EHS Specialist II
Limerick
Senior Manufacting Engineer
Republic of Ireland
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