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
R&D Engineer
Galway
Senior R&D Engineer
Clare
Senior R&D Engineer
Galway
R&D Manager
Galway
R&D Engineer
Galway
Maintenance & Reliability Technician
Limerick
Learning Systems Lead
Limerick
Project Manager - R&D
Galway
R&D Engineer
Galway
Quality Systems Manager
Dublin
Senior Reg Affairs Specialist - Post Mar
Galway
Principal Process Equipment Engineer
Dublin South
Senior R&D Manager - Lifecycle Manag
Galway
Senior Maintenance Technician
Roscommon
Lead Maintenance Technician
Kilkenny
Senior R&D Engineer
Dublin
Senior Quality Assurance Specialist (hyb
Dublin
R&D Engineer
Clare
Quality Specialist
Clare
Senior Microbiologist
Dublin
Project Manager
Kildare
Technical Life Cycle & Engineering M
Galway
Reg Affairs Specialist
Connaught
R&D Manager
Dublin
Design Assurance Engineer
Clare
Sourcing Specialist
Tipperary
Process Development Engineer
Galway
Principal Engineer
Dublin
Quality Assurance Associate
Cork
Senior Operations Engineer
Galway
Product Development Engineer
Dublin
Manufacturing Engineer
Galway
Regulatory Affairs Associate
Cork
Senior Quality Engineer
Galway
Product Development Engineer
Dublin
Quality Specialist
Clare
Senior Quality Engineer
Dublin
R&D Engineer
Galway
Senior R&D Engineer
Galway
Senior Quality Engineer
Dublin
Project Manager
Galway
Senior Quality Engineer
Leitrim
R&D Engineer
Galway
R&D Director
Galway
Manufacturing Engineer
Galway
Manufacturing Technician
Clare
Product Development Manager
Galway
QA Engineer
Leitrim
Manufacturing Technician
Galway
Senior R&D Engineer
Galway
Product Development Engineer
Dublin
Project Manager (hybrid)
Dublin
Senior Quality Engineer
Dublin
Calibration Technician
Republic of Ireland
Senior Product Development Engineer
Galway
Production Operator
Meath
Analytical Scientist
Meath
Principal Engineer
Dublin
Manufacturing Engineer
Cork
Quality Manager
Galway
Senior R&D Engineer
Dublin
R&D Director
Galway
Senior Validation Engineer
Louth
Senior Process Engineer
Carlow
Quality Assurance Engineer
Longford
Senior R&D Engineer
Galway
Quality Engineer
Athlone
Project Engineer
Limerick
Cleaning Validation Specialist
Cork
Sr Electrical Engineer
Galway
Senior R&D Engineer
Galway
Principal R&D Engineer
Galway
Senior Equipment Design Engineer
Dublin
Quality Engineer
Galway
Design Quality Engineer
Galway
Electronic Engineer
Dublin
Senior Mechanical Engineer
Dublin
Senior Quality Engineer
Dublin
Documentation Specialist
Louth
Senior R&D Engineer
Galway
Senior Quality Engineer
Galway
Senior Regulatory Specialist
Cork
Embedded Software Engineer
Dublin
Product Development Engineer II
Athlone
R&D Lifecycle Manager
Connaught
Process Engineer
Roscommon
Quality Engineer
Athlone
R&D Manager
Athlone
Principal R&D Engineer
Galway
Documentation Specialist
Louth
R&D Manager
Galway
Senior R&D Engineer
Galway
Senior Process Engineer
Dublin
Senior Quality Engineer
Dublin
Value Stream Team Leader / Production Su
Wexford
Injection Molding Engineer
North Leinster
Senior Manufacting Engineer
Republic of Ireland
Warehouse Operator
Meath
Project Manager - R&D
Galway
Quality Assurance Specialist (Logistics)
Dublin
Logistics Associate
Dublin
R&D Manager
Athlone
R&D Engineer
Galway
Senior Product Development Engineer
Galway
Senior Design Assurance Engineer
Galway
Technical Marketing Manager
Wexford
Clinical Research Associate
Cork
Maintenance Reliability Engineer
Cork
Senior Regulatory Affairs Specialist
Athlone
Product Specialist (Endoscopy)
Dublin
R&D Engineer
Dublin
Senior Quality Engineer
Dublin
Operations Engineer
Galway
R&D Manager
Galway
Purchasing & Planning Manager
Wexford
Senior Electronic Engineer
Dublin
Injection Moulding Engineer
Athlone
Senior Regulatory Affairs Specialist
Athlone
Clinical Research Associate
Cork
R&D Engineer
Galway
Senior Project Engineer - R&D
Galway
Senior R&D Engineer
Galway
Territory Manager (Woundcare)
Cork
Clinical Research Manager
Cork
Validation & Verification Engineer
Dublin
R&D Project Manager
Galway
Injection Molding Engineer
North Leinster
Documentation Specialist
Louth
R&D Manager
Connaught
Sr Electrical Engineer
Galway
Electronic Engineer
Dublin
CTO
Galway
Sales/Customer Service Administrator
Clonmel
Quality Manager - NPI
Dublin
Senior Tech Transfer Specialist
Meath
Manufacturing Technician
Clare
Senior R&D Engineer
Galway
Director Engineering & Supply Chain
Galway
Senior Design Engineer
Dublin
Senior R&D Engineer
Galway
Shift Technician (Injection Moulding)
Kildare
Biostatistician
Dublin
Director of Regulatory Affairs
Galway
Software Design Assurance Engineer
Dublin
Manufacturing Engineer
Galway
Engineering Shift Technician
Dublin
Mechanical Engineer
Dublin
Senior R&D Engineer
Galway
Senior Design Engineer
Dublin
Electronic Engineering
Dublin
Director of Quality Engineering
Limerick
Senior R&D Engineer
Dublin
Responsible Person (RP)
Republic of Ireland
Project Manager Design Assurance
Galway
Strategic Automation Lead
Waterford
Senior R&D Manager - Lifecycle Manag
Galway
Quality Engineer
Galway
Senior Electronics Engineer
Dublin
Maintenance CMMS Engineer
Tipperary
Design Assurance Engineer
Clare
Senior Recruitment Consultant
Republic of Ireland
R&D Manager
Connaught
Injection Moulding Engineer
Leitrim
Change Control SME
Cork
Quality Engineer
Galway
Senior Associate Quality Control (Shift)
Dublin
Mechanical Technician
Carlow
Manufacturing Technician
Clare
Senior Operations Engineer
Galway
Senior Equipment Design Engineer
Dublin
Senior R&D Manager
Athlone
Injection Molding Engineer
North Leinster
Electrical Condition Monitoring Technici
Limerick
Senior Technical Transfer Specialist
Cork
R&D Engineer
Galway
Maintenance Technician
Kilkenny
QA Manager
Canada
Senior Recruitment Consultant
Dublin
R&D Manager
Galway
Principal R&D Engineer
Galway
Senior QC Microbiology
Dublin
Electronic Engineer
Dublin
R&D Engineer
Dublin
Process Chemist
Limerick
R&D Engineer
Galway
Senior Engineering Manager
Limerick
Product Development Technician II
Galway
R&D Director
Galway
Process Engineer
Dublin
R&D Manager
Galway
Project Manager
Kildare
Quality Engineer
Galway
E&I Turnover Engineer
Carlow
CTO
Dublin
R&D Director
Galway
Process Engineer
Roscommon
Principal Device Engineer
Dublin
Regulatory Associate
Cork
Manufacturing Engineer
Wexford
Lead Maintenance Technician
Kilkenny
Product Development Engineer
Dublin
Quality Engineer
Galway
Reliability Engineering Consultant - Rem
Republic of Ireland
Product Specialist (Peripheral Endovascu
Dublin
R&D Manager
Connaught
Injection Molding Engineer
North Leinster
R&D Manager
Connaught
Facilities Engineer
Carlow
Product Development Engineer II
Athlone
R&D Technician II
Galway
Senior Design Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Production Operator
Carlow
Senior Regulatroy Affairs Specialsit
Galway
R&D Engineer
Galway
Project Engineer - Senior
Cavan
Senior Equipment Design Engineer
Dublin
Health & Safety Specialist
Dublin
Senior Recruitment Consultant
Republic of Ireland
Quality Assurance Team Lead
Cork
EHS Officer
Dublin
Quality Specialist
Tipperary
Associate Analytical Scientist
Meath
Senior Regulatory Affairs Specialist
Dublin
Consultant




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

Regulatory Specialist

Title: Regulatory Specialist Location: Galway business park, Galway Benefits: Salary, bonus, pension, hybrid working and healthcare Overview: As a Regulatory Specialist you will support the commercialisation of Medical Device products. This includes preparation and submission of regulatory filings for product market entry, as well as regulatory activities required for the maintenance of existing commercial products. The position requires a high level of innovative thought and problem-solving skills. In order to coordinate the variety of regulatory related task...

Location: Galway, Galway City,
Regulatory Specialist 		Galway Not Disclosed

Regulatory Associate

Role: Regulatory Associate Location: Bishopstown, Cork Benefits: Top salary, Hybrid working, bonus, pension and healthcare Company: My client are an innovative Cork-based med‑tech spin‑out disrupting paediatric ENT care with a streamlined, in‑office ear‑tube insertion device. They've scaled from Irish clinical success to U.S. regulatory approval and global roll‑out under a German multinational company. With a strong IP portfolio, seasoned leadership, and growing market presence, they&rs...

Location: Cork,
Regulatory Associate 		Cork 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.