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
Associate Director External Supply
Dublin
Quality Assurance Associate
Cork
Regulatory Affairs Manager- Remote
Republic of Ireland
Senior Quality Engineer
Dublin
Senior Electronics Engineer
Limerick
QA Engineer
Leitrim
Sterilisation Manager
Tipperary
Senior Regulatory Affairs
Galway
CQV /CSV Quality Assurance Specialist (H
Dublin
Quality Engineer
Galway
QA Operations Specialist
Dublin
Project Manager
Kildare
QC Micro Analyst (4 cycle shift)
Cork
Maintenance & Reliability Technician
Limerick
Strategic Automation Lead
Waterford
Biomedical Engineer
Dublin
R&D Director
Galway
Technical Life Cycle & Engineering M
Galway
Sr Project Manager - Syringe Fill Engine
Dublin
Graduate Occupational Hygiene Consultant
Kildare
R&D Engineer
Galway
Supply Chain Specialist - New Material I
Meath
Senior Associate QC (QC Sample Managemen
Dublin
Equipment Engineer (Syringe Inspection S
Dublin
Senior Design Assurance Engineer
Galway
Principal Design Assurance Engineer
Galway
Validation Engineer
Carlow
Product Development Engineer
Dublin
Principal Software Engineer
Athlone
Continuous Improvement Coach
Limerick
Senior Maintenance Technician
Roscommon
R&D Manager
Galway
Design Assurance Engineer
Galway
Senior R&D Engineer
Clare
Quality Technician
Galway
Responsible Person (RP)
Republic of Ireland
Senior Product Development Engineer
Galway
Senior Equipment Design Engineer
Dublin
Product Development Manager
Galway
Business Development Manager (Hospitals)
Cork
Senior Quality Engineer
Dublin
Quality Engineer
Galway
R&D Manager
Connaught
R&D Technician II
Galway
Quality Assurance Team Lead
Cork
Quality Assurance Specialist (shift)
Carlow
Regulatory Affairs Specialist
Cork
Key Account Manager - Retail UK National
South East
Senior Electronics Engineer
Dublin
Manufacturing Technician
Galway
Calibration Technician
Republic of Ireland
Senior Quality Engineer
Dublin
Senior Electronic Engineer - Regulated M
Galway
Senior Process Engineer
Dublin
Senior R&D Engineer
Galway
Strategy Associate Director / Director -
Dublin
R&D Manager
Connaught
R&D Engineer
Galway
Senior Research and Development Engineer
Galway
Senior Quality Systems Engineer
Galway
Facilities Engineer
Wexford
Injection Moulding Engineer
Athlone
Senior R&D Manager - Lifecycle Manag
Galway
Regulatory Affairs Manager - Senior
Galway
Product Development Engineer II
Athlone
Design Assurance Program Manager
Galway
Senior Regulatory Affairs Specialist
Dublin
Senior Regulatory Affairs Manager
Galway
Advanced Technologies R&D Manager
Clare
NPI Engineer - Hybrid
Dublin
Regulatory Affairs Maanger
Galway
Senior Equipment Engineer
Dublin
Senior R&D Engineer
Galway
Senior Quality Engineer
Galway
Quality Control Analyst (shift)
Carlow
Principal Process Equipment Engineer
Dublin South
Product Development Engineer
Galway
Product Development Engineer II
Athlone
Principal R&D Engineer
Galway
Manufacturing Specialist - Investigation
Dublin
Quality Manager - NPI
Dublin
Senior Maintenance Technician
Kilkenny
R&D Manager
Galway
Principal Engineer
Dublin
Principal Device Engineer
Dublin
Business Manager (Critical Care & Me
Dublin
Quality Assurance Specialist
Carlow
Mechanical Technician
Carlow
Purchasing & Planning Manager
Wexford
Principal Engineer
Dublin
Continuous Improvement Coach
Limerick
Senior Microbiologist
Dublin
Injection Moulding Engineer
Athlone
Senior Product Development Engineer
Galway
Sr Principal R&D Engineer
Galway
Senior Design Engineer
Dublin
Accreditation Manager
Republic of Ireland
Design Assurance Engineer
Galway
Senior Production Supervisor
Galway City
R&D Engineer
Galway
Microbiology Manager
Dublin
R&D Manager
Athlone
Engineering Shift Technician
Dublin
Operations Engineer
Galway
R&D Manager
Dublin
Senior Manufacturing Engineer
Galway City
Senior Research & Development Engine
Limerick
Senior Operations Engineer
Galway
Senior R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Quality Specialist
Tipperary
Quality Engineer
Athlone
Senior NPI Engineer - Hybrid
Dublin
Senior QC Microbiology
Dublin
R&D Director
Galway
Validation Engineer
Athlone
Quality Assurance Specialist/Manager
Dublin
Senior Design Assurance Engineer
Athlone
QC Bioanalytical Sciences - Senior Assoc
Dublin
Technical Support Specialist - Drug Subs
Louth
Project Manager
Kildare
Quality Engineer
Galway
Senior Reg Affairs Specialist - Post Mar
Galway
R&D Director
Galway
Project Manager (hybrid)
Dublin
Business Development Manager
Republic of Ireland
Senior Project Engineer - R&D
Galway
Senior Product Development Engineer
Galway
R&D Manager
Connaught
Engineering Support Specialist
Louth
Quality Engineer
Galway
Principal Design Assurance Engineer
Galway
Principal Design Assurance Engineer
Galway
Senior R&D Engineer
Galway
R&D Manager
Connaught
Health & Safety Specialist
Louth
Tech Transfer Lead - Sterile Drug Produc
Dublin
Manufacturing Technician
Clare
Advanced Technologies Manager
Galway
Quality Manager - Medical Devices
Limerick City
Manufacturing Technician
Clare
R&D Manager
Athlone
Principal Reliability Engineer
Galway
Documentation Specialist
Louth
Quality Assurance Specialist (Hybrid)
Dublin
Learning Systems Lead
Limerick
Embedded Software Engineer
Dublin
Senior Design Engineer
Dublin
R&D Engineer
Galway
Change Control Specialist
Tipperary
Quality Engineer
Galway
Electrical Condition Monitoring Technici
Limerick
Quality Technician
Dublin
R&D Engineer
Clare
R&D Engineer
Galway
Process Engineer
Galway
Staff R&D Engineer
Limerick
R&D Engineer
Dublin
CTO
Galway
Project Engineer
Clare
Senior R&D Engineer
Dublin
Process Engineer
Carlow
Senior Design Assurance Engineer
Galway
R&D Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Process Chemist
Limerick
Dental- Manager/ Senior Manager Business
Republic of Ireland
Senior Manufacting Engineer
Republic of Ireland
R&D Manager
Galway
Design Assurance Manager
Galway
Senior Quality Engineer
Leitrim
Product Development Engineer
Dublin
Senior Quality Engineer
Dublin
Health & Safety Specialist
Dublin
Commercial Attribute Science Snr Associa
Dublin
QA Manager
Canada
Senior Regulatroy Affairs Specialsit
Galway
Senior Electronic Engineer
Dublin
Director of R&D
Limerick
Industrial Designer
Galway
CQV Engineer
Dublin
Principal R&D Engineer
Dublin
Senior Quality Engineer
Dublin
Injection Moulding Engineer
Leitrim
Documentation Specialist
Louth
Sterilisation Manager
Tipperary
Manufacturing Technician
Clare
R&D Engineer
Galway
Quality Engineer
Athlone
Senior Principal Design and Development
Galway
Senior Research Scientist
Galway
Sales/Customer Service Administrator
Clonmel
Production Operator
Meath
Warehouse Operator
Meath
Commercial Attribute Science Scientist
Dublin
Senior Design Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
CTO
Dublin
Quality Engineer
Athlone
Senior Quality Engineer
Galway
Software Design Assurance Engineer
Dublin
Product Specialist (Endoscopy)
Dublin
Senior Regulatory Affairs Specialist
Clare
R&D Engineer
Galway
Product Development Engineer
Galway
Electronic Engineering
Dublin
R&D Manager
Galway
Quality Assurance Engineer
Longford
Senior R&D Engineer
Galway
Senior Equipment Design Engineer
Dublin
Senior Process Engineer - DP or DS
Dublin
Quality Specialist
Clare
Quality Engineer
Galway
Injection Moulding Engineer
Athlone
Senior Quality Control Associate
Dublin South
Production Manager
Dublin
R&D Manager
Galway
Process Development - Senior Project Man
Dublin
Clinical Trial Manager
Republic of Ireland
Senior R&D Engineer
Galway
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