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
Hot Science Jobs
EHSS Specialist (Construction & Comm
Athlone
Senior Mechanical Engineer
Dublin
Manufacturing Specialist (Investigation
Dublin
Senior R&D Engineer
Galway
Quality Manager - NPI
Dublin
Calibration Planner & Scheduler
Carlow
Principal R&D Engineer
Galway
QA Manager
Canada
Senior Manager - Contract Manufacturing
Republic of Ireland
Quality Specialist
Clare
Production Operator
Meath
Quality Manager
Dublin
Senior Research and Development Engineer
Galway
Sr Project Manager - Syringe Fill Engine
Dublin
Operations Engineer
Galway
Quality Manager - Medical Devices
Limerick City
Manufacturing Technician
Galway
Senior Regulatory Affairs Specialist
Athlone
Quality Manager
Galway
Process Engineer
Galway
Industrial Designer
Galway
Pharmacovigilance Manager (Remote)
Republic of Ireland
Senior Equipment Design Engineer
Dublin
Senior Associate Quality Control
Dublin
Senior QC Associate - Micro
Dublin
Quality Manager
Galway
R&D Engineer
Galway
Marketing Manager
Galway
Advanced Technologies Manager
Galway
Key Account Executive (Hospital Pharmaci
Dublin
Senior Reg Affairs Specialist - Post Mar
Galway
Senior Regulatory Affairs Specialist
Dublin
Product Development Engineer
Dublin
Principal Engineer
Dublin
Senior Electronic Engineer
Dublin
Senior QC Technical Services Specialist
Dublin
Software Design Assurance Engineer
Dublin
Senior Quality Assurance Engineer
Galway
Equipment Engineer (Syringe filling)
Dublin
Senior Quality Engineer
Galway
Senior Regulatory Affairs Specialist
Clare
Maintenance Technician (Electrical/Mecha
Dublin
R&D Manager
Connaught
Senior Design Engineer
Dublin
Senior Engineering Manager
Galway
Senior Project Engineer - Utilities Syst
Donegal
QA Engineer
Leitrim
Director Engineering & Supply Chain
Galway
Senior Quality Assurance Associate
Dublin
CQV Engineer
Roscommon
Senior QC Microbiology
Dublin
Laboratory Technician (Microbiology &
Dublin
Group Head of Commercial
Dublin
Product Development Engineer
Galway
R&D Manager
Galway
Process Development - Senior Project Man
Dublin
R&D Engineer
Galway
Operations Manager
Galway
Process Chemist
Limerick
Senior Operations Engineer
Galway
Clinical Trial Protocol Specialist
Galway
Advanced Technologies R&D Manager
Clare
Embedded Software Engineer
Dublin
Director of R&D
Galway
Senior R&D Engineer
Limerick
Senior Project Engineer
Cork
Senior R&D Engineer
Galway
Principal Software Engineer
Athlone
Quality Technician
Dublin
Senior Design Assurance Engineer
Galway
R&D Engineer
Galway
CTO
Galway
Senior Regulatory Specialist
Cork
Senior Quality Engineer
Dublin
Quality Manager
Galway
Director of R&D
Limerick
Manufacturing Technician
Clare
R&D Engineer
Galway
R&D Engineer II
Galway
R&D Engineer
Galway
Senior Quality Engineer
Dublin
Production Manager
Wexford
R&D Manager
Athlone
Senior Product Development Engineer
Galway
Process Development Engineer
Galway
Senior QC Associate (Bioassay)
Dublin
Senior Quality Engineer
Galway
R&D Technician
Galway
Senior Maintenance Technician
Kilkenny
Senior Regulatory Affairs Manager
Galway
Lead MSAT Validation Consultant
Republic of Ireland
Validation Engineer
Athlone
R&D Manager
Galway
Continuous Improvement Specialist
Dublin
Senior Director of Manufacturing and Sup
Galway
R&D Senior Program Manager
Galway
Business Development Manager (Hospitals)
Cork
Quality Assurance Specialist
Carlow
Senior Electronic Engineer
Limerick
Instrumentation Engineer
Meath
Senior Product Development Engineer
Galway
Sr Electrical Engineer
Galway
Head of Data Partnerships & Operatio
Dublin
R&D Manager
Athlone
Project Engineer
Clare
Program Manager
Galway
Senior Product Development Engineer
Galway
CTO
Dublin
Senior Manufacturing Engineer
Galway City
Product Specialist (Critical Care &
Dublin
Senior Project Manager
Meath
Senior Design Engineer
Dublin
Staff Systems Engineer
Limerick
Senior Project Engineer - R&D
Galway
Senior QC Analyst
Republic of Ireland
Quality Assurance Senior Specialist
Louth
Responsible Person (RP)
Republic of Ireland
Analytical Science Associate & Speci
Carlow
Senior Regulatroy Affairs Specialsit
Galway
R&D Manager
Galway
R&D Manager
Galway
Product Development Engineer II
Athlone
Senior Regulatory Affairs Specialist
Athlone
R&D Engineer
Dublin
Senior Engineering Manager
Galway
Mechanical Technician
Carlow
Senior Quality Engineer
Dublin
Senior R&D Product Engineer
Galway
Digital & Technology Manager
Dublin
Staff R&D Engineer
Limerick
Senior Equipment Design Engineer
Dublin
Senior Design Assurance Engineer
Galway
LIMS Specialist
Tipperary
R&D Manager
Galway
QC Specialist
Clare
Senior Project Engineer
Cavan
Injection Molding Engineer
Mayo
Product Development Technician II
Galway
QA Operations Specialist
Meath
Senior Design Assurance Engineer
Galway
R&D Engineer
Galway
Senior Product Development Engineer
Galway
Project Engineer
Cork
Global Safety Senior Manager
Republic of Ireland
Industrial Engineer Capacity Planning
Dublin
Senior Equipment Engineer
Dublin
Sales/Customer Service Administrator
Clonmel
Senior Quality Engineer
Leitrim
Senior QA Specialist
Dublin
Business Resilience Specialist
Dublin
Senior Regulatory Affairs Specialist
Athlone
Principal Engineer
Dublin
Operational Excellence Lead
Dublin
Process Engineer - Sterile Drug Product
Waterford
Warehouse Operator
Dublin
Business Development Director
Dublin
Senior Electronics Engineer
Limerick
Electrical Condition Monitoring Technici
Limerick
Senior R&D Engineer
Limerick
Documentation Specialist
Louth
Manufacturing Technician
Clare
Senior Quality Engineer
Dublin
Senior Design Engineer
Dublin
Proposal Manager
Dublin
Quality Assurance Team Lead
Cork
Quality Specialist
Tipperary
Quality Manager RP
Dublin
Quality Systems Manager
Dublin
R&D Director
Galway
Head of Data Partnerships & Operatio
Dublin
Senior Electronic Engineer - Regulated M
Galway
Key Account Manager (Hospital Pharmacies
Offaly
Business Development Manager
Republic of Ireland
Key Account Manager - Retail UK National
South East
Utilities Engineer
Dublin
Manufacturing Engineer
Galway
QA Specialist
Carlow
NPD Quality Manager
Galway
R&D Engineer
Galway
Project Manager
Kildare
EAP Portfolio Manager
Republic of Ireland
Distribution Partner Manager (Life Scien
Dublin
Director of R&D
Clare
R&D Lifecycle Manager
Connaught
Quality Manager
Galway
Quality Manager
Galway
EHSS Specialist
Athlone
Laboratory Systems Specialist
Meath
Manufacturing Specialist - Investigation
Dublin
Principal Design and Development Enginee
Galway
R&D Manager
Dublin
Senior Equipment Design Engineer
Dublin
Project Manager - New Product Introducti
Dublin
R&D Manager
Connaught
Director of Quality Engineering
Limerick
Injection Moulding Engineer
Athlone
R&D Engineer
Galway
Manufacturing Technician
Clare
Senior Quality Engineer
Dublin
Senior R&D Engineer
Galway
Principal R&D Engineer
Galway
R&D Engineer
Dublin
R&D Engineer
Galway
Senior Quality Assurance Engineer
Galway
Senior Quality Assurance Technical Suppo
Dublin
Senior Operations Engineer
Galway
Production Planner
Kildare
R&D Engineer
Galway
Quality Engineer
Athlone
Senior Maintenance Technician
Kilkenny
Senior Manufacting Engineer
Republic of Ireland
Senior R&D Engineer
Galway
Quality Assurance Specialist
Carlow
Quality System & Regulatory Affairs
Galway
Senior R&D Engineer
Galway
A.I Specialist
Clare
Quality Assurance Specialist (Logistics)
Dublin
Senior Electronics Engineer
Dublin
R&D Program Manager
Dublin
R&D Director
Galway
R&D Technician II
Galway
Clinical Sales Specialist (Histology)
Dublin
Senior Quality Engineer
Dublin
Senior Quality Assurance Specialist (hyb
Dublin
Senior Process Development Engineer
Dublin
Senior Engineering Manager
Limerick
Principal R&D Engineer
Dublin
Senior Quality Engineer
Leitrim
R&D Engineer
Clare
Senior R&D Manager
Athlone
Senior Quality Engineer
Dublin
R&D Manager
Connaught
Electronic Engineering
Dublin
R&D Director
Galway
Design Assurance Manager
Galway
Project Manager
Kildare
Project Manager
Galway
Advanced Technologies R&D Manager
Clare
Calibration Technician
Republic of Ireland
Senior R&D Engineer
Dublin
R&D Manager
Connaught
Senior R&D Engineer
Clare
Quality Manager
Galway
Senior R&D Engineer II
Galway
Quality Manager
Galway
Quality Engineer
Galway
Senior Design Assurance Engineer
Galway
Quality Assurance Specialist (hybrid)
Dublin
Senior Operations Engineer
Galway
Quality Assurance Specialist (shift)
Carlow
Senior Specialist MS&T
Dublin
Consultant




Search Results for Regulatory Affairs Clinical Research
Job Title. Location Salary Actions

Quality Manager

Title: QA / RA Manager Location: ATU Ihub, Dublin Road, Galway Company: My client are a Medical are an early-stage start-up focused on developing patient solutions in the area of palliative care. Their initial technology platform is a catheter-based device used to treat the build-up of fluid in the body. Role: QARA Manager with DA focus on a 9-month contract basis who will thrive in a multidisciplinary start-up environment. Looking for people that are curious, have a similar strong work ethic to our own, and are motivated by the positive influe...

Location: Galway, Galway City,
Quality Manager 		Galway Not Disclosed

Quality Manager

Title: QA / RA Manager Location: ATU Ihub, Dublin Road, Galway Company: My client are a Medical are an early-stage start-up focused on developing patient solutions in the area of palliative care. Their initial technology platform is a catheter-based device used to treat the build-up of fluid in the body. Role: QARA Manager with DA focus on a 9-month contract basis who will thrive in a multidisciplinary start-up environment. Looking for people that are curious, have a similar strong work ethic to our own, and are motivated by the positive influe...

Location: Galway, Galway City,
Quality Manager 		Galway Not Disclosed

Quality Manager

Title: QA / RA Manager Location: ATU Ihub, Dublin Road, Galway Company: My client are a Medical are an early-stage start-up focused on developing patient solutions in the area of palliative care. Their initial technology platform is a catheter-based device used to treat the build-up of fluid in the body. Role: QARA Manager with DA focus on a 9-month contract basis who will thrive in a multidisciplinary start-up environment. Looking for people that are curious, have a similar strong work ethic to our own, and are motivated by the positive influe...

Location: Galway, Galway City,
Quality Manager 		Galway Not Disclosed

Senior Regulatory Affairs Manager

Job title: Sr Regulatory Affairs Manager Location: Mervue, Galway Benefits: Top salary, bonus, pension, healthcare and car allowance Overview: As the Senior Manager of Regulatory Affairs, you play a key leadership role within the Acute Care & Monitoring (ACM) operating unit, supporting regulatory activities for a portfolio of products. This role entails implementing regulatory strategies, managing regulatory submissions, assessing the regulatory impact of product changes, and ensuring your team delivers high-quality results ...

Location: Galway, Galway City,
Senior Regulatory Affairs Manager 		Galway Not Disclosed

Regulatory Affairs Manager - Senior

Job title: Sr Regulatory Affairs Manager Location: Mervue, Galway Benefits: Top salary, bonus, pension, healthcare and car allowance Overview: As the Senior Manager of Regulatory Affairs, you play a key leadership role within the Acute Care & Monitoring (ACM) operating unit, supporting regulatory activities for a portfolio of products. This role entails implementing regulatory strategies, managing regulatory submissions, assessing the regulatory impact of product changes, and ensuring your team delivers high-quality results...

Location: Galway, Galway City,
Regulatory Affairs Manager - Senior 		Galway Not Disclosed

Reg Affairs Specialist

Role: Regulatory Affairs Engineer Location: Parkmore, Galway (Hybrid working) Benefits: Top salary Company: My client are a growing Medical Device company who have recently moved into a high tech new site in Parkmore. They have developed an innovative new technology to improve the performance of Vascular stents. Role: Reporting to the Senior Regulatory Affairs Manager, as a Regulatory Affairs Specialist you will play a key a key role in the implementation of post-market activities within Veryan. This is a ...

Location: Connaught, Galway, Galway City, Leitrim, Limerick,
Reg Affairs Specialist 		EU Not Disclosed

Senior Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist Location: Parkmore, Galway. 1 day a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Reporting to the Se...

Location: Athlone, Clare, Connaught, Galway, Galway City,
Senior Regulatory Affairs Specialist 		EU Not Disclosed

Senior Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist Location: Parkmore, Galway. 1 day a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Reporting to the Se...

Location: Athlone, Clare, Connaught, Galway, Galway City,
Senior Regulatory Affairs Specialist 		EU Not Disclosed

Senior Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist Location: Parkmore, Galway. 1 day a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Reporting to the Se...

Location: Athlone, Clare, Connaught, Galway, Galway City,
Senior Regulatory Affairs Specialist 		EU Not Disclosed

Senior Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Reporting to the Senior Reg...

Location: Athlone, Clare, Connaught, Galway, Galway City,
Senior Regulatory Affairs Specialist 		EU Not Disclosed

Senior Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist – Post market Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Rep...

Location: Athlone, Clare, Connaught, Galway, Galway City,
Senior Regulatory Affairs Specialist 		EU Not Disclosed

Senior Reg Affairs Specialist - Post Market

Job title: Senior Regulatory Affairs Specialist – Post market Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Reporting to t...

Location: Galway, Galway City,
Senior Reg Affairs Specialist - Post Market 		Galway Not Disclosed

Senior Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist – Premarket Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Company: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. This role is best suited to an individual who is self-motivated, accountable and seeking infinite learning and growth opportunities. Role: As a Senior Regulatory Affairs Specialist you will will pl...

Location: Clare, Connaught, Galway, Galway City, Limerick,
Senior Regulatory Affairs Specialist 		EU Not Disclosed
Subscribe RSS feed for this search

Regulatory Affairs Clinical Research Career Profile

Regulatory Affairs Clinical Research


Working in a CRO (Clinical Research Organisation) means working on large projects simultaneously. The regulatory filing for every stage of the clinical trial needs to be looked after for progress on the drug to be made. Below is an example Spec for a Senior role in a CRO:

Key Responsibilities

  • Liaise directly with regulatory bodies such as EMA & National Competent Authorities and you will maintain relations with key contacts
  • Work as part of the EMEA Regulatory team.
  • Evaluate data, review documentation and support/prepare documentation for medicinal products and medicals devices, as appropriate, for all stages of product development i.e. CTA through to life cycle maintenance
  • Maintain an accurate record of the time and direct costs associated with each project for which you are responsible and where appropriate produce status reports.
  • You will support the Regulatory Project Lead and dependent on the size of and nature of the project assigned, you may act as the Regulatory Project Lead and you will deal directly with the sponsor and Regulatory Agencies
  • Control all project related documentation either in paper or electronic form.

Skills / Experience

  • Must have 4-5 Yrs in a similar position.
  • Must have a science degree in a related field.
  • Knowledge of European guidelines and be able to review and evaluate CMC, Pre-Clinical and/or Clinical data in compliance with the relevant guidance.
  • Excellent communication and interpersonal skills, both written and verbal enabling you to deal with queries in a timely manner.