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
Sinead Cullen
Life Science

01 507 9252
[email protected]
Connect with me on
Hot Science Jobs
Facilities Engineer
Carlow
Quality Technical Services Manager - 12
Dublin
R&D Engineer
Galway
Quality Control NPI Senior Associate
Dublin South
Senior Maintenance Technician
Carlow
R&D Director
Galway
QA Associate Specialist - Shift
Carlow
QA Manager
Canada
Quality Systems Specialist
Galway
Reliability Engineering Specialist
Louth
Maintenance Engineer
Carlow
R&D Manager
Galway
Senior Design Engineer
Dublin
Technical Sales Manager (Chemistry)
Westmeath
Commissioning and Qualification Engineer
Cork
Senior Electronic Engineer
Dublin
Senior R&D Engineer
Clare
CQV Lead
Tipperary
Director of Quality Engineering
Limerick
Project Engineer
Republic of Ireland
Medical Writer
Cork
R&D Engineer
Galway
Strategic Automation Lead
Waterford
Product Development Engineer II
Athlone
Sourcing Specialist
Tipperary
Injection Molding Engineer
North Leinster
Process Validation Engineer
Cork
R&D Manager
Athlone
Clinical Research Program Manager
Galway
Senior R&D Manager/Director
Dublin
Value Stream Team Leader / Production Su
Wexford
Staff R&D Engineer- Customer Focus
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Product Lead
Dublin
Senior Manager Device Supplier Assurance
Dublin
Project Manager - R&D
Galway
Senior Process Engineer
Cork
Production Operator
Carlow
Quality Systems Manager
Dublin
Principal Engineer
Dublin
C&Q Lead
Tipperary
Senior Recruitment Consultant
Dublin
Senior Director Statistics Data and Anal
Cork
Technical Transfer Specialist - Remote
Republic of Ireland
Buyer
Wexford
Project Manager - Suite Lead
Tipperary
Senior Validation Engineer
Limerick
Maintenance Reliability Engineer
Cork
Senior Regulatory Affairs Specialist
Athlone
Quality Control Technician
Carlow
Project Engineer - Senior
Cavan
Senior R&D Project Manager
Galway
Commisioning and Qualification Engineer
Cork
Senior R&D Engineer
Galway
Technology Transfer Specialist (Technica
Cork
Project Engineer
Roscommon
R&D Manager
Athlone
Senior Quality Engineer
Limerick
Principal Device Engineer
Dublin
R&D Manager
Galway
Cleaning Validation Specialist
Cork
Injection Molding Engineer
North Leinster
R&D Manager
Connaught
Senior R&D Manager - Lifecycle Manag
Galway
R&D Manager
Dublin
Process Engineer - Water Formulations
Limerick
Scientist (hybrid)
Meath
Chemical Engineer
Tipperary
Lead Maintenance Reliability Engineer
Westmeath
Validation Specialist
Cork
Process Development Engineer
Galway
Validation Engineer
Carlow
Senior Quality Engineer
Dublin
Senior Validation Engineer
Cork
Quality Specialist
Clare
Senior Associate Quality Control
Dublin
Technical Life Cycle & Engineering M
Galway
Product Development Manager
Galway
R&D Engineer
Galway
Senior Project Engineer
Cork
Quality Specialist
Tipperary
Injection Molding Engineer
North Leinster
Upstream Manufacturing Process Specialis
Cork
Senior Associate Quality Control NPI
Dublin
Senior R&D Engineer
Dublin
Senior Process Engineer
Cork
Principal Scientist Device and Product P
Dublin
Maintenance Reliability Engineer
Tipperary
Manufacturing Technician
Clare
Account Manager UK and Ireland
Republic of Ireland
Process Engineer (NPI)
Carlow
Principal R&D Engineer
Galway
Technical Administrator
Tipperary
Senior Quality Engineer-Remote
Republic of Ireland
Microbiology Manager
Dublin
NPI Process Engineer
Carlow
Advanced Technologies R&D Manager
Clare
Process Engineer
Cork
Cleaning Validation Specialist
Cork
R&D Engineer
Galway
Project Engineer
Limerick
Production Operator
Carlow
Senior Validation Engineer
Dublin
Senior Manufacting Engineer
Republic of Ireland
Instrument Specialist
Tipperary
R&D Director
Galway
R&D Manager
Connaught
QA Manager
Canada
R&D Manager
Galway
Principal Process Equipment Engineer
Dublin South
Clinical Affairs Specialist
Galway
Senior Design Assurance Engineer
Galway
Senior R&D Engineer
Dublin
Project Manager
Limerick
Senior Research and Development Engineer
Galway
Technical Transfer Engineer - Drug Subst
Louth
Quality Engineer
Galway
Senior R&D Engineer
Dublin
R&D Director
Galway
Project Manager - R&D
Galway
Maintenance CMMS Engineer
Tipperary
Maintenance Engineer
Cork
Senior Project Engineer
Cavan
Senior R&D Engineer
Galway
Product Development Engineer
Galway
Senior Technical Scientist - Technical T
Cork
R&D Engineer
Dublin
Manufacturing Technician
Clare
Quality Technician
Dublin
Senior Technical Transfer Engineer
Cork
(Senior) Manufacturing Engineers - Globa
Limerick
QC External Sample and Retain Coordinato
Carlow
Principal/Senior R&D Engineer Cathet
Galway
Pharmacovigilance Manager (Remote)
Republic of Ireland
Senior R&D Engineer
Clare
Mechanical Technician - 2 Cycle
Carlow
Project Process Engineer
Carlow
R&D Program Manager
Dublin
Quality Assurance Engineer
Longford
Senior Validation Engineer
Dublin
Shift Technician (Injection Moulding)
Kildare
Senior Equipment Design Engineer
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Senior Quality Engineer
Galway
Packaging Engineer
Dublin
Validation Engineer
Limerick
Senior Regulatory Affairs Specialist
Dublin
Engineering Shift Technician
Dublin
Material Handler
Carlow
QA Engineer
Leitrim
Regulatory Affairs Specialist
Cork
Technical Transfer Specialist
Cork
R&D Manager
Galway
Principal Engineer
Dublin
Senior R&D Engineer
Galway
Manufacturing Technician
Clare
Senior Reg Affairs Specialist - Post Mar
Galway
R&D Engineer
Galway
Cleaning Validation Specialist
Cork
Validation & Verification Engineer
Dublin
Quality Specialist
Tipperary
Senior Maintenance Technician
Roscommon
Senior QC Associate
Dublin
Senior Mechanical Engineer
Dublin
Senior Quality Engineer
Dublin
R&D Director
Galway
Maintenance CMMS Engineer
Tipperary
Senior Quality Engineer
Leitrim
Process Engineer (Shift)
Carlow
R&D Manager
Connaught
Head of R&D
Galway
Engineering Projects Lead
Carlow
Principal R&D Engineer
Dublin
R&D Senior Program Manager
Galway
R&D Engineer
Galway
Senior Quality Engineer
Leitrim
Manufacturing Technician
Clare
Cleaning Validation Specialist
Carlow
Quality Engineer
Galway
Senior Project Engineer - Utilities
Dublin
R&D Engineer
Galway
Senior Recruitment Consultant
Republic of Ireland
Senior Recruitment Consultant
Republic of Ireland
Electronic Design Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Project Enginer
Dublin South
Senior R&D Engineer
Galway
Manufacturing Engineer
Limerick
R&D Engineer
Clare
Supply Chain Manager (hybrid)
Dublin
Senior Project Equipment Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Applications Scientist
Dublin
Senior Microbiologist
Dublin
Senior Project Manager - Process Develop
Dublin
R&D Engineer
Dublin
Senior Equipment Design Engineer
Dublin
Quality Manager - NPI
Dublin
Quality Control Technician
Carlow
Principal Instrumentation Engineer
Limerick
Change Control Coordinator
Carlow
R&D Manager
Connaught
Senior R&D Manager - Lifecycle Manag
Galway
Principal R&D Engineer
Galway
Project Manager
Galway
Product Development Engineer II
Athlone
Senior QC 24/7 Shift
Dublin
QC Laboratory Technician (shift)
Carlow
Clinical Project Manager
Cork
Biostatistician
Dublin City Centre
Senior Electrical Engineer
Galway
Process Engineer
Limerick
Senior Human Factors Engineer
Dublin
Project/Process Engineer - Purification
Cork
Cleaning Validation Specialist
Cork
Senior Quality Engineer
Leitrim
R&D Engineer
Galway
Senior Technical Transfer Specialist
Cork
Senior Microbiologist
Republic of Ireland
Principal R&D Engineer
Dublin
Aseptic Process Lead
Carlow
Senior Electronic Design Engineer
Dublin
Process Support Specialist
Carlow
Process Simulation Technical Engineer
Carlow
Project Manager - R&D
Galway
Product Development Engineer II
Athlone
Commissioning, Qualification and Valid
Carlow
Responsible Person (RP)
Republic of Ireland
Electrical Engineer
Cork
Validation Engineer
Athlone
Manufacturing Technician
Clare
Recruitment Consultant
Republic of Ireland
Quality Engineer
Galway
Project Engineer
Tipperary
Quality Technician
Dublin
Senior Microbiology Specialist - Greece
Republic of Ireland
Project Engineer - Senior
Cavan
Process Chemist
Limerick
QA Compliance Specialist
Carlow
Manufacturing Biotech Associate 24/7 Shi
Meath
Senior R&D Engineer
Dublin
Senior Quality Engineer
Leitrim
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

Clinical Affairs Specialist


Reference:SCA014502 Location: Galway
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Clinical Data Manager, Clinical Project Manager, Clinical Research Associate, Clinical Research Nurse

Clinical Affairs Specialist
Our client, a medical device company, are currently recruiting for a Clinical Affairs Specialist on a permanent basis. As Clinical Affairs Specialist you will assist with the design, planning and execution of clinical trials. You will also prepare and submit applications for clinical investigations. This role offers hybrid working.

Responsibilities

  • Prepare clinical documents for submission to Ethics Committees, Institutional Review Boards and regulatory authorities such as the FDA and Competent Authorities
  • Liaise with external vendors such as CROs, core labs, and biostatisticians
  • Liaise with study coordinators and investigational site personnel to coordinate clinical trial activities
  • Assist with tracking patient enrolment and data management
  • Support regulatory activities related to clinicals
  • Ensure clinical data is correctly documented and analysed
  • Adhere to SOPs, Good Clinical Practice regulations, and other relevant regulatory requirements
Requirements
  • Degree in Engineering or Science discipline
  • Minimum of 2 years’ experience in the medical device or pharmaceutical industry
  • Understanding of clinical trial requirements and Good Clinical Practice. Regulatory experience is an advantage.
  • Excellent interpersonal & communication skills essential
  • Excellent writing skills and comprehension skills
  • Experience working in an SME environment desirable, preferably in a medtech start-up
  • Commit to ongoing personal development to improve technical and non-technical skillsets
  • Experience in preparation of clinical trial documentation desirable
For more information, please contact Sinéad Cullen on +353879500821