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 Manager
Galway
R&D Lifecycle Manager
Connaught
Senior R&D Manager - Lifecycle Manag
Galway
Senior Quality Engineer
Dublin
CTO
Galway
Senior Quality Engineer
Dublin
Advanced Technologies Manager
Galway
Senior Quality Engineer
Dublin
Principal R&D Engineer
Dublin
Principal Design and Development Enginee
Galway
Quality Systems Manager
Dublin
Design Assurance Engineer
Galway
Process Chemist
Limerick
Associate Director External Supply
Dublin
Senior R&D Engineer
Clare
Senior Regulatory Affairs Specialist
Clare
Senior Quality Engineer
Leitrim
Quality Assurance Specialist
Carlow
Project Manager (Pharma)
Dublin
Electrical Technician
Limerick
Marketing Manager
Galway
R&D Manager
Connaught
Sales/Customer Service Administrator
Clonmel
R&D Senior Program Manager
Galway
Quality Engineer - Supplier
Galway
R&D Manager
Dublin
R&D Manager
Galway
Business Development Manager (Hospitals)
Cork
CQV /CSV Quality Assurance Specialist (H
Dublin
Commercial Attribute Science Snr Associa
Dublin
Product Development Engineer II
Athlone
Quality Manager - Medical Devices
Limerick City
Senior Electronic Engineer
Dublin
R&D Manager
Connaught
Senior Electronic Engineer
Dublin
Quality Engineer
Galway
Senior R&D Engineer II
Galway
Sterilisation Manager
Tipperary
Advanced Technologies R&D Manager
Clare
Senior QC Associate
Dublin
Senior Quality Engineer
Dublin
Shift Technician (Injection Moulding)
Kildare
Quality Engineer
Galway
R&D Manager
Galway
R&D Engineer
Galway
Quality Technician
Galway
Quality Technician
Dublin
R&D Manager
Athlone
Distribution Manager (Chemicals)
Dublin
Senior R&D Manager
Athlone
Injection Moulding Engineer
Athlone
R&D Engineer
Galway
Quality Specialist
Dublin
Senior Associate QC (QC Sample Managemen
Dublin
Manufacturing Technician
Clare
Senior Manufacting Engineer
Republic of Ireland
Quality Engineer - Supplier
Galway
Senior Design Assurance Engineer
Galway
Technical Life Cycle & Engineering M
Galway
Sr Principal R&D Engineer
Galway
Injection Moulding Engineer
Athlone
Senior Regulatory Specialist
Cork
Principal R&D Engineer
Galway
Senior QC Systems Validation Associate
Dublin
Project Engineer
Clare
Quality Engineer
Galway
Senior R&D Engineer-New Product Deve
Westmeath
Senior Contract Development & Manufa
Dublin
R&D Engineer
Clare
R&D Engineer
Galway
Senior R&D Engineer
Dublin
Product Development Engineer
Galway
Product Development Manager
Galway
Director of R&D
Limerick
Senior R&D Engineer
Galway
Senior Equipment Engineer
Dublin
Embedded Software Engineer
Dublin
Process Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Construction Manager - Pharma/Biotech
Dublin
Principal Device Engineer
Dublin
Continuous Improvement Coach
Limerick
Regulatory Affairs Manager- Remote
Republic of Ireland
Calibration Technician
Republic of Ireland
Senior Research Engineer
Galway
R&D Engineer
Dublin
Project Manager (hybrid)
Dublin
Quality Engineer
Athlone
Senior Electronic Engineer - Regulated M
Galway
Senior Quality Assurance Specialist
Cork
QA Operations Specialist
Dublin
Responsible Person (RP)
Republic of Ireland
Process Engineer
Carlow
Quality Engineer
Galway
R&D Manager
Athlone
Accreditation Manager
Republic of Ireland
Health & Safety Specialist
Dublin
R&D Program Manager
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
QC Bioanalytical Sciences - Senior Assoc
Dublin
Senior Operations Engineer
Galway
Quality Assurance Specialist (shift)
Carlow
Pharmacovigilance Manager (Remote)
Republic of Ireland
Senior R&D Engineer
Galway
Quality Specialist
Clare
Supply Chain Specialist - New Material I
Meath
Manufacturing Technician
Clare
Quality Assurance Associate
Cork
Documentation Specialist
Louth
Facilities Engineer
Wexford
Senior Process Engineer
Dublin
R&D Director
Galway
Project Manager
Kildare
Senior Regulatory Affairs Manager
Galway
Production Manager
Dublin
Senior Product Development Engineer
Galway
Senior Principal R&D Engineer
Galway City
Product Development Technician II
Galway
Supplier Quality Engineer
Galway
Product Specialist (Critical Care &
Dublin
Quality Engineer
Wexford
Product Development Engineer II
Athlone
Maintenance & Reliability Technician
Limerick
Tech Transfer Lead - Sterile Drug Produc
Dublin
R&D Director
Galway
Design Assurance Program Manager
Galway
Senior Design Assurance Engineer
Galway
Senior R&D Engineer
Galway
Operations Engineer
Galway
Technical Transfer Specialist - Remote
Republic of Ireland
Business Development Manager
Republic of Ireland
Senior R&D Engineer
Galway
Quality Manager - NPI
Dublin
CTO
Dublin
Senior Operations Engineer
Galway
Senior Reg Affairs Specialist - Post Mar
Galway
R&D Engineer
Galway
Principal Engineer
Dublin
Senior Manufacturing Specialist
Dublin
Senior Design Assurance Engineer
Galway
R&D Engineer
Galway
Manufacturing Technician
Galway
R&D Technician II
Galway
R&D Manager
Connaught
R&D Director
Galway
Project Manager - R&D
Galway
Supply Chain Specialist - New Material I
Meath
Senior Regulatory Affairs Specialist
Athlone
Equipment Engineer (Syringe filling)
Dublin
Senior Product Development Engineer
Galway
Quality Specialist
Tipperary
R&D Manager
Galway
Quality Engineer
Galway
Senior Equipment Design Engineer
Dublin
Business Manager (Woundcare, Orthopaedic
Dublin
(Senior) Manufacturing Engineers - Globa
Limerick
Supplier Quality Engineer
Galway
Commercial Solutions Manager (Medical De
Dublin
Senior Design Assurance Engineer
Galway
R&D Engineer
Dublin
Business Manager (Critical Care & Me
Dublin
Senior Quality Assurance Technical Suppo
Dublin
Engineering Business Manager
Dublin
Senior R&D Manager
Athlone
Senior Research Scientist
Galway
Injection Moulding Engineer
Leitrim
Senior QA Specialist
Dublin
Senior Regulatory Affairs Specialist
Athlone
Senior R&D Engineer
Galway
Senior Electronics Engineer
Dublin
R&D Manager
Connaught
Senior Design Assurance Engineer
Athlone
Regulatory Affairs Manager - Senior
Galway
QA Manager
Canada
Senior Maintenance Technician
Kilkenny
Dental- Manager/ Senior Manager Business
Republic of Ireland
Senior Design Engineer
Dublin
Senior Electronic Engineer
Dublin
Clinical Trial Manager
Republic of Ireland
Technical Support Specialist - Drug Subs
Louth
R&D Engineer
Galway
Application Software Engineer
Galway
Senior Design Engineer
Dublin
Senior R&D Engineer
Dublin
Quality Assurance Specialist (shift)
Carlow
Senior Equipment Design Engineer
Dublin
Product Specialist (Endoscopy)
Dublin
Senior Maintenance Technician
Kilkenny
Senior Regulatory Specialist
Cork
Advanced Technologies R&D Manager
Clare
Senior Design Assurance Engineer
Galway
Quality Engineer
Athlone
Senior Production Supervisor
Galway City
Mechanical Engineer
Dublin
Microbiology Manager
Dublin
Supply Chain Project Manager (hybrid)
Dublin
QA Engineer
Leitrim
Sterilisation Manager
Tipperary
Senior R&D Manager - Lifecycle Manag
Galway
Senior Process Development Engineer
Galway
R&D Manager
Galway
Senior Quality Engineer
Galway
Director Engineering & Supply Chain
Galway
Senior Equipment Design Engineer
Dublin
R&D Director
Galway
Continuous Improvement Coach
Limerick
Senior QC Associate (Bioassay)
Dublin
CQV Engineer
Dublin
Senior R&D Engineer
Galway
Key Account Manager (Retail & Pharm
Dublin
Quality Engineer
Athlone
Graduate Occupational Hygiene Consultant
Kildare
Manufacturing Technician
Clare
Project Manager
Galway
Principal R&D Engineer
Dublin
Electrical Condition Monitoring Technici
Limerick
R&D Engineer
Galway
Biomedical Engineer
Dublin
Injection Moulding Engineer
Athlone
Senior Product Development Engineer
Galway
Project Manager
Kildare
Senior R&D Engineer
Dublin
Quality Technician
Dublin
Senior Regulatory Affairs
Galway
Product Development Engineer II
Athlone
Consultant




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

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

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.