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
Pharmacovigilance Manager (Remote)
Republic of Ireland
Injection Moulding Engineer
Athlone
R&D Manager
Galway
QC Bioanalytical Sciences - Senior Assoc
Dublin
R&D Engineer
Galway
Senior R&D Engineer
Galway
Senior Microbiologist
Dublin
Quality Engineer
Galway
Senior Equipment Design Engineer
Dublin
Quality Manager
Dublin
Director of Regulatory Affairs
Galway
Senior R&D Engineer
Galway
Quality Engineer
Galway
Embedded Software Engineer
Dublin
Senior Quality Engineer
Leitrim
Quality Engineer
Wexford
Product Development Engineer
Dublin
Senior Electronic Engineer
Dublin
Product Development Manager
Galway
Product Development Engineer
Dublin
Production Operator
Meath
Project Manager - R&D
Galway
Project Engineer
Clare
R&D Manager
Connaught
Project Manager
Kildare
Senior R&D Engineer
Clare
Electrical Technician
Limerick
Senior Recruitment Consultant
Republic of Ireland
Senior Operations Engineer
Galway
Senior Equipment Design Engineer
Dublin
Quality Engineer
Galway
Principal Design and Development Enginee
Galway
Staff R&D Engineer
Limerick
Principal R&D Engineer
Galway
Senior Quality Systems Engineer
Galway
R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Dublin
R&D Manager
Galway
Technology Transfer Specialist
Meath
Research & Develpment Manager
Galway
Technical Life Cycle & Engineering M
Galway
Documentation Specialist
Louth
Quality Manager
Dublin
Senior R&D Engineer
Galway
Production Manager
Dublin
Manufacturing Technician
Galway
Learning & Performance Training Asso
Dublin
Senior R&D Engineer
Clare
R&D Manager
Dublin
Calibration Technician
Republic of Ireland
Senior Quality Engineer
Leitrim
Senior Quality Engineer
Dublin
Process Development Engineer
Galway
Sr R&D Manager
Galway
Senior R&D Engineer - Sustaining
Galway
Quality Assurance Engineer
Longford
R&D Engineer
Galway
Senior R&D Engineer
Galway
R&D Director
Galway
Principal R&D Engineer
Galway
Project Engineer
Roscommon
Senior R&D Engineer
Galway
Technical Life Cycle & Engineering M
Galway
Sr Electrical Engineer
Galway
Manufacturing Technician
Clare
Mechanical Engineer
Dublin
R&D Manager
Galway
Senior Associate Quality Control (Shift)
Dublin
Associate Analytical Scientist
Meath
Mechanical Technician - 2 Cycle
Carlow
Principal R&D Engineer
Galway
Manufacturing Technician
Galway
Senior R&D Engineer
Galway
Senior Quality Assurance Specialist (hyb
Dublin
Maintenance & Reliability Technician
Limerick
Lead Maintenance Reliability Engineer
Westmeath
R&D Manager
Athlone
Senior Design Engineer
Dublin
Project Manager Design Assurance
Galway
Materials Controller (Biopharma - Limeri
Limerick
R&D Manager
Galway
Electronic Engineering
Dublin
Manufacturing Technician
Clare
Responsible Person (RP)
Republic of Ireland
Validation & Verification Engineer
Dublin
Design Assurance Engineer
Clare
R&D Engineer
Clare
Senior Quality Engineer
Dublin
Advanced Technologies R&D Manager
Clare
Project Engineer
Limerick
Documentation Specialist
Louth
Reg Affairs Specialist
Connaught
Sr R&D Manager
Galway
Operational Excellence Specialist
Cork
R&D Technician II
Galway
Clinical Research Associate
Cork
Senior cGxP Laboratory Technician
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Senior R&D Engineer
Dublin
Regulatory Affairs Associate
Cork
Quality Specialist
Tipperary
Procurement Executive
Dublin
Senior Associate Quality Control
Dublin
Electronic Engineer
Dublin
Production Operator
Carlow
Senior Technical Transfer Specialist
Cork
R&D Engineer
Galway
Engineering Support Specialist
Louth
Electronic Engineer
Dublin
Senior Process Engineer
Longford
Product Development Engineer II
Athlone
Product Development Engineer
Dublin
Senior R&D Engineer
Dublin
Principal R&D Engineer
Dublin
Sr R&D Manager
Galway
Quality Assurance Senior Specialist
Louth
Injection Molding Engineer
North Leinster
Senior Quality Engineer
Galway
Senior Quality Engineer
Dublin
Microbiology Manager
Dublin
Quality Control Analyst (shift)
Carlow
CTO
Dublin
Manufacturing Project Engineer
Sligo
Injection Molding Engineer
North Leinster
R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Product Specialist (Peripheral Endovascu
Dublin
Project Manager
Louth
Senior Quality Engineer
Dublin
Sales/Customer Service Administrator
Clonmel
Quality Specialist
Clare
Principal R&D Engineer
Galway
Growth Manager (Healthcare)
Dublin
Design Assurance Engineer
Clare
Senior Process Engineer
Dublin
Senior Operations Engineer
Galway
Shift Technician (Injection Moulding)
Kildare
Senior Regulatory Affairs Specialist
Athlone
Quality Assurance Specialist (hybrid)
Dublin
Senior R&D Engineer
Dublin
Senior Design Engineer
Dublin
Product Specialist (Endoscopy)
Dublin
Software Design Assurance Engineer
Dublin
R&D Director
Galway
Cleaning Validation Specialist
Cork
Manufacturing Engineer
Cork
R&D Engineer
Dublin
Project Manager Design Assurance
Galway
Project Manager - New Product Introducti
Dublin
Project Manager - R&D
Galway
Senior R&D Engineer
Galway
Quality Engineer
Galway
Principal R&D Engineer
Galway
R&D Manager
Connaught
Principal R&D Engineer
Galway
QA Engineer
Leitrim
Continuous Improvement Coach
Limerick
R&D Engineer
Galway
Senior Recruitment Consultant
Dublin
Senior R&D Engineer
Galway
Project Manager
Galway
Senior Quality Control Associate
Dublin South
Senior Manufacting Engineer
Republic of Ireland
R&D Senior Program Manager
Galway
CTO
Galway
Quality Engineer
Galway
Senior Regulatory Specialist
Cork
Maintenance Manufacturing Technician
Kilkenny
Design Assurance Engineer
Galway
R&D Engineer
Galway
Site Microbiologist
Republic of Ireland
R&D Manager
Connaught
Process Chemist
Limerick
Process Engineer
Galway
Principal Reliability Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
R&D Engineer
Dublin
Biomedical Engineer
Dublin
Regulatory Associate
Cork
Senior Manufacturing Engineer
Galway
Cleaning Validation Specialist
Cork
Electronic Engineer
Dublin
Senior R&D Engineer-New Product Deve
Westmeath
Senior R&D Engineer
Galway
R&D Engineer
Galway
Principal Research and Development Engin
Galway
Product Development Engineer
Galway
Senior R&D Engineer
Galway
Senior Reg Affairs Specialist - Post Mar
Galway
Documentation Specialist
Louth
Engineering Support Specialist
Louth
Clinical Research Associate
Cork
Project Manager (hybrid)
Dublin
Senior R&D Engineer
Galway
QA Manager
Canada
Senior Electronics Engineer
Dublin
R&D Manager
Athlone
Sr Electrical Engineer
Galway
Senior Design Assurance Engineer
Galway
Senior R&D Engineer
Galway
Quality Technician
Dublin
Quality Assurance Team Lead
Cork
Senior Process Development Engineer
Galway
Electronic Engineer
Dublin
Senior Electronic Engineer
Dublin
Senior Electronic Engineer - Regulated M
Galway
Validation Engineer
Athlone
R&D Manager
Connaught
Project Engineer
Cork
Quality Manager
Galway
R&D Manager
Galway
Sr Electrical Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Senior R&D Manager
Athlone
R&D Engineer
Galway
R&D Director
Galway
Senior Validation Engineer
Louth
Project Manager
Kildare
Quality Systems Manager
Dublin
R&D Director
Galway
Senior Recruitment Consultant
Republic of Ireland
Senior R&D Engineer
Galway
R&D Engineer
Galway
Health & Safety Specialist
Dublin
Quality Manager - Medical Devices
Limerick City
Facilities Engineer
Carlow
Consultant




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

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

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.