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
Senior Operations Engineer
Galway
Electronic Engineering
Dublin
Mechanical Design Engineer
Germany
Product Development Engineer
Dublin
Microbiology Manager
Dublin
R&D Engineer
Galway
Electronic Engineer
Dublin
Principal Engineer
Dublin
Production Operator
Meath
Product Development Engineer
Galway
Electronic Engineer
Dublin
Production Operator
Carlow
Electronic Engineer
Dublin
R&D Engineer
Dublin
Process Engineer (NPI)
Carlow
Project Manager
Galway
Process Engineer
Galway
Principal Process Development Engineer
Galway
R&D Engineer
Dublin
Account Manager UK and Ireland
Republic of Ireland
Principal Heart Valves Engineer
Galway
R&D Manager
Athlone
Project Manager Design Assurance
Galway
R&D Manager
Connaught
Senior Electrical Engineer
Galway
Senior QA Associate (Shift)
Dublin
Senior Regulatory Affairs Specialist
Clare
R&D Manager
Dublin
Senior R&D Engineer
Clare
Senior R&D Engineer
Galway
Senior R&D Engineer-New Product Deve
Westmeath
Product Development Technician
Galway
Senior Design Assurance Engineer
Galway
R&D Engineer
Galway
QC Separation Analyst
Cork
Maintenance Technician
Carlow
Manufacturing Engineer
Galway
Senior Regulatory Specialist
Cork
Electronic Design Engineer
Galway
R&D Manager
Athlone
Senior R&D Engineer
Dublin
Associate QA Specialist (Shift)
Carlow
Senior R&D Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Project Manager - R&D
Galway
Sales/Customer Service Administrator
Clonmel
Senior R&D Engineer
Dublin
Senior QC Microbiology
Dublin
R&D Engineer
Galway
Advanced Technologies Manager
Galway
Quality Control Technician
Carlow
Project Manager - R&D
Galway
Principal Quality Engineer
Galway
Quality Specialist
Tipperary
Senior Electronic Engineer
Dublin
Injection Moulding Engineer
Athlone
Senior Regulatory Affairs Specialist
Athlone
Associate Director - Global Core Labelin
Cork
Cleaning Validation Specialist
Cork
Senior Quality Engineer
Galway
Quality Engineer
Athlone
National Retail Sales Manager (Ireland)
Dublin
Senior Process Development Engineer
Galway
Senior R&D Engineer
Galway
Senior Technical Transfer Specialist
Cork
Quality Technical Services Manager - 12
Dublin
QA Operations Specialist (hybrid)
Meath
Technical Life Cycle & Engineering M
Galway
Product Development Engineer
Galway
Senior Technical Transfer Engineer - Hyb
Carlow
Senior Associate Quality Control
Dublin
R&D Director
Galway
R&D Manager
Galway
Manufacturing Engineer
Cork
Injection Molding Engineer
North Leinster
Project Engineer
Roscommon
Product Development Manager
Galway
Technical Administrator
Tipperary
Project Manager Design Assurance
Galway
CTO
Dublin
Quality Specialist & Deputy RP
Limerick
Scientist (hybrid)
Meath
Process Simulation Technical Engineer
Carlow
SAP Analyst - Logistics & Supply Cha
Limerick
Production Operator
Dublin
R&D Engineer
Clare
Senior Quality Engineer
Leitrim
Senior Project Manager - Process Develop
Cork
Project Manager - R&D
Galway
Senior Recruitment Consultant
Republic of Ireland
Senior Polymer Development Engineer
Galway
R&D Director
Galway
Senior Cleaning Validation Engineer
Carlow
R&D Engineer
Galway
Director of Regulatory Affairs
Galway
Senior Design Assurance Engineer
Athlone
QA Manager
Canada
Senior R&D Engineer
Galway
Regulatory Affairs Associate
Cork
Senior Analytical Scientist
Cork
Senior Electronics Engineer
Limerick
QC Systems Specialist
Dublin
Senior Recruitment Consultant
Dublin
Quality Engineer
Athlone
Maintenance Technician
Kilkenny
Principal/Senior R&D Engineer Cathet
Galway
Principal Device Engineer
Dublin
R&D Engineer
Galway
Senior Quality Engineer
Leitrim
R&D Engineer
Galway
Design Assurance Program Manager
Galway
R&D Engineer
Galway
Associate Director Global Regulatory Aff
Cork
Clinical Seating Specialist (Dublin)
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Quality Technician
Dublin
Operations Manager
Galway
Senior Process Engineer
Cork
Senior Electronic Design Engineer
Dublin
Quality Engineer
Galway
Principal Equipment Engineer
Dublin
Senior Equipment Engineer
Dublin
Senior Equipment Design Engineer
Dublin
Senior R&D Engineer
Galway
Electronic Engineer
Dublin
Program Manager
Dublin
R&D Senior Program Manager
Galway
Quality Manager
Dublin
R&D Manager
Galway
Senior Electronics Engineer
Dublin
R&D Manager
Galway
Process Development Engineer
Galway
Quality Specialist
Tipperary
Operations Engineer
Galway
Injection Molding Engineer
North Leinster
Project Manager - R&D
Galway
Principal Process Development Engineer
Galway
Associate Director Clinical Development
Republic of Ireland
Quality Control Technician
Carlow
R&D Director
Galway
Manufacturing Technician
Clare
Manufacturing Engineer
Wexford
(Senior) Manufacturing Engineers - Globa
Limerick
Senior R&D Manager/Director
Dublin
R&D Program Manager
Dublin
Embedded Software Engineer
Dublin
Associate R&D Engineer
Galway
Senior Human Factors Engineer
Dublin
Principal Process Development Engineer
Dublin
Project Engineer - Senior
Cavan
Operations Excellence Lead
Louth
Product Development Technician II
Galway
Head of R&D
Galway
Project Engineer
Limerick
Senior Maintenance Technician
Roscommon
Senior Associate Quality Control NPI
Dublin
Quality Control NPI Senior Associate
Dublin South
Validation Engineer
Athlone
MS&T Associate Director
Dublin
R&D Engineer
Galway
Value Stream Team Leader / Production Su
Wexford
Senior Recruitment Consultant
Republic of Ireland
R&D Director
Galway
Regulatory Affairs Specialist
Cork
Senior R&D Engineer
Dublin
Quality Manager
Galway
R&D Project Manager
Galway
EHS Specialist
Meath
Senior Quality Engineer
Dublin
Validation & Verification Engineer
Dublin
Regional Program Coordinator - Global Le
Dublin
Process Engineer (NPI)
Carlow
Senior Manufacting Engineer
Republic of Ireland
Quality Engineer
Galway
Principal Equipment Engineer
Dublin
Principal Engineer - R&D
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Biostatistician
Dublin City Centre
Manufacturing Engineer
Galway
Electronic Engineer
Dublin
Senior Quality Engineer-Remote
Republic of Ireland
Senior Electronic Engineer
Dublin
DeltaV Lead Automation Engineer
Tipperary
Reliability Engineer
Tipperary
R&D Technician II
Galway
Quality Engineer
Galway
R&D Engineer
Galway
Product Development Engineer
Dublin
R&D Engineer
Galway
Associate Director Clinical Development
Cork
Principal R&D Engineer
Galway
R&D Engineer
Galway
Senior Cleaning Validation Engineer
Carlow
Senior Associate QC
Dublin
Senior Project Manager - Process Develop
Dublin
Senior Operations Engineer
Galway
Responsible Person (RP)
Republic of Ireland
Quality Director
Galway
Senior QC Microbiology (Shift)
Dublin
Senior Design Engineer
Dublin
Senior Human Factors Engineer
Dublin
Quality Assurance Engineer
Longford
Senior QC 24/7 Shift
Dublin
Senior Microbiologist
Dublin
R&D Manager
Galway
Principal Engineer
Dublin
Advanced Technologies R&D Manager
Clare
Notified Body Product Assessor -Active D
Canada
R&D Manager
Connaught
E&I Turnover Engineer
Carlow
Validation Specialist - 50/50 remote
Carlow
Quality Engineer
Galway
Senior Quality Engineer
Dublin
Medical Writer
Cork
R&D Engineer
Galway
NPI Process Engineer
Carlow
Senior Equipment Design Engineer
Dublin
Product Application Specialist (IVD) - I
Dublin
Engineering Business Manager
Dublin
QA Manager
Canada
Senior Operations Engineer
Galway
Engineering Shift Technician
Dublin
Quality Manager - Medical Devices
Limerick City
Operations Engineer
Galway
Senior Associate Quality Control
Dublin
R&D Manager
Connaught
Engineering Projects Lead
Carlow
Process Engineer
Cork
Technical Life Cycle & Engineering M
Galway
Senior Design Assurance Engineer
Clare
QA Engineer
Leitrim
Senior R&D Manager
Athlone
R&D Manager
Connaught
Senior Regulatory Affairs Specialist
Athlone
Senior QC ELN Associate - Electronic Not
Dublin
Principal Equipment Engineer
Dublin
Associate R&D Engineer
Galway
NPI Process Engineer
Carlow
Quality Engineer
Athlone
Process Chemist
Limerick
Principal Process Equipment Engineer
Dublin South
Consultant




Search Results for Regulatory Affairs Specialist
Job Title. Location Salary Actions

Associate Director - Global Core Labeling (Regulatory Affairs)

Associate Director - Global Core Labeling (Regulatory Affairs) -FTC Our client is a global healthcare leader with employees around the world who work to discover and bring life-changing medicines to those who need them. They are seeking a Global Labelling Lead who shall be at Associate Director level to join a growing team of Regulatory professionals within their Global Business Centre.The purpose of the Associate Director, Global Regulatory Affairs (GRA) Global Core Labeling role is to lead the development and maintenance of global labeling, including all core la...

Location: Cork,
Associate Director - Global Core Labeling (Regulatory Affairs) 		Cork Not Disclosed

Associate Director Global Regulatory Affairs

Associate Director Global Regulatory Affairs Our client, a global pharma company, are currently recruiting for an Associate Director Global Regulatory Affairs to join their team on a permanent basis. People management experience is essential for this role. This role offers hybrid working. Responsibilities: People Management: Recruit, develop, and retain a diverse and highly capable workforce Ensure robust individual training plans and timely completion of required training for direct reports Support and enable talent identification and career development that re...

Location: Cork,
Associate Director Global Regulatory Affairs 		Cork Not Disclosed

Associate Director - Global Core Labeling (Regulatory Affairs)

Associate Director - Global Core Labeling (Regulatory Affairs) Our client is a global healthcare leader with employees around the world who work to discover and bring life-changing medicines to those who need them. They are seeking a Global Labelling Lead who shall be at Associate Director level to join a growing team of Regulatory professionals within their Global Business Centre.The purpose of the Associate Director, Global Regulatory Affairs (GRA) Global Core Labeling role is to lead the development and maintenance of global labeling, including all core labelin...

Location: Cork,
Associate Director - Global Core Labeling (Regulatory Affairs) 		Cork Not Disclosed

Associate Director Global Regulatory Affairs

Associate Director Global Regulatory Affairs Our client, a global pharma company, are currently recruiting for an Associate Director Global Regulatory Affairs to join their team on a permanent basis. People management experience is essential for this role. This role offers hybrid working. Responsibilities: People Management: Recruit, develop, and retain a diverse and highly capable workforce Ensure robust individual training plans and timely completion of required training for direct reports Support and enable talent identification and career development that refl...

Location: Cork,
Associate Director Global Regulatory Affairs 		Cork 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

Regulatory Affairs Specialist

Regulatory Affairs Specialist (Remote/Hybrid) Our client a high potential start up medical device company currently seeks a Regulatory Affairs Specialist to join their team. Reporting to the Clinical and Regulatory Affairs Manager, the Regulatory Specialist will be responsible for helping with compliance to standards, regulatory submissions and annual reporting to the notified body and FDA. The Regulatory Affairs Specialist must have a working knowledge of medical device regulatory requirements and standard practices in the medical device industry. This position re...

Location: Cork,
Regulatory Affairs Specialist 		Cork Not Disclosed

Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist Our client a Medical Device Multinational currently seeks a Senior Regulatory Specialist to join their team. The Senior. Regulatory Affairs Specialist will develop strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction. The Sr. Regulatory position will assist in mentoring and development of staff members as part of the role. Role/Responsibilities • Manage Technical Documentation ...

Location: Westmeath,
Senior Regulatory Affairs Specialist 		Westmeath Not Disclosed
Subscribe RSS feed for this search

Regulatory Affairs Specialist Career Profile

Regulatory Affairs Specialist

There are Regulatory Affairs (RA) opportunities available in a variety of industries: Pharmaceutical / Biotech / Agrochemical / Clinical Research Organisations (CRO's). There also exist roles in Consultancy organisations, companies which service small and large Clients in the above industries, on various projects. These can often be interesting and varied roles for the experienced RA professional.

Salary Scale:


  • Regulatory Affairs Assistant - €25,000 - €28,000
  • Regulatory Affairs Officer - €32,000 - €39,000
  • Regulatory Affairs Specialist - €40,000 - €55,000
  • Regulatory Affairs Manager - €60,000 - €80,000
  • Regulatory Affairs Director - €85,000 +

Role Responsibilities:

  • Life cycle management and Maintenance of regulatory filings including annual reports and supplements to US FDA.
  • Preparation of registration submissions, in CTD (Clinical Trial Dossier) format, for pharmaceutical products for approval by the US FDA, European Regulatory Authorities and worldwide, as required.
  • Monitoring the progress of registration submissions, responding to queries and ensuring that registration approvals are granted without undue delays.
  • Regulatory Compliance, for change control activities monitoring the impact of changes in regulatory submissions.
  • Monitoring adverse events for submissions, preparation and review and generation of supporting documents for potential field alerts and recalls.
  • Maintenance of approvals, including the preparation of annual reports for US products.
  • Assess and review documentation to ensure compliance with product licences.
  • Undertake general regulatory activities that interface with other departments such as Manufacturing, Product Development, Quality Control and Quality Assurance.
  • Actively participate in project teams, as required.

Industry Experience:

  • Minimum of 3 years regulatory experience in the pharmaceutical industry.
  • Knowledge of the current regulatory requirements, particularly US and EU.
  • Experience in writing and submitting regulatory documentation.