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 Quality Assurance Specialist
Cork
Project Manager - New Product Introducti
Dublin
Staff Systems Engineer
Limerick
Process Engineer
Roscommon
Quality Assurance Senior Specialist
Louth
QA Manager
Canada
Project Manager - R&D
Galway
Product Development Engineer
Galway
Senior Quality Engineer
Leitrim
Design Assurance Program Manager
Galway
Quality Engineer
Athlone
Senior R&D Engineer
Galway
R&D Manager
Galway
Quality Assurance Team Lead
Cork
Project Engineer
Clare
Senior R&D Manager - Lifecycle Manag
Galway
Senior Research & Development Engine
Limerick
Principal R&D Engineer
Galway
Electronic Engineer
Dublin
Senior Equipment Design Engineer
Dublin
Calibration Technician
Republic of Ireland
Senior Product Development Engineer
Galway
Technical Life Cycle & Engineering M
Galway
Senior Manufacting Engineer
Republic of Ireland
Business Development Manager (Pharma &am
Republic of Ireland
R&D Manager
Athlone
R&D Manager
Dublin
Technical Marketing Manager
Wexford
R&D Engineer
Clare
Senior Maintenance Technician
Roscommon
R&D Manager
Connaught
Director of Quality Engineering
Limerick
Senior Electronic Engineer
Dublin
Quality Assurance Specialist (hybrid)
Dublin
Senior Regulatory Specialist
Cork
Quality Manager
Galway
Manufacturing Technician
Clare
R&D Engineer
Galway
Process Engineer
Galway
Senior Design Engineer
Dublin
Senior Manufacturing Engineer
Galway City
EHS Officer
Dublin
Design Assurance Engineer
Clare
Senior Electronic Engineer
Dublin
R&D Engineer
Galway
R&D Director
Galway
Manufacturing Technician
Clare
Senior Process Engineer
Galway
Engineering Support Specialist
Louth
Design Assurance Engineer
Galway
Clinical Research Associate
Cork
Technical Life Cycle & Engineering M
Galway
Senior Project Engineer
Cavan
Senior R&D Engineer
Dublin
Senior Design Assurance Engineer
Galway
Engineering Business Manager
Dublin
R&D Engineer
Dublin
R&D Senior Program Manager
Galway
R&D Director
Galway
Senior Regulatory Affairs Specialist
Athlone
Quality Engineer
Galway
R&D Manager
Connaught
Senior R&D Engineer
Galway
Senior R&D Engineer
Galway
Learning Systems Lead
Limerick
Senior Electrical Engineer
Galway
Manufacturing Technician
Clare
Responsible Person (RP)
Republic of Ireland
Senior Operations Engineer
Galway
Process Chemist
Limerick
Principal Process Equipment Engineer
Dublin South
Product Development Engineer
Dublin
Biomedical Engineer
Dublin
Validation Engineer
Athlone
Product Development Engineer II
Athlone
Senior Associate Quality Control
Dublin
Quality Manager - NPI
Dublin
Project Manager Design Assurance
Galway
Quality Manager
Dublin
Senior Quality Control Associate
Dublin South
Product Development Engineer
Galway
R&D Scientist (Microbiology)
Wexford
Senior Regulatory Specialist
Cork
Quality Technician
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Senior Regulatory Affairs Specialist
Clare
Contract Development & Manufacturing
Dublin
R&D Engineer
Galway
Senior Reg Affairs Specialist - Post Mar
Galway
Quality Assurance Associate
Cork
Clinical Research Associate
Cork
R&D Engineer
Galway
(Senior) Manufacturing Engineers - Globa
Limerick
R&D Engineer
Galway
Senior Quality Assurance Specialist (hyb
Dublin
R&D Engineer
Dublin
Regulatory Affairs Manager - Senior
Galway
Senior Quality Engineer
Dublin
Project Manager - R&D
Galway
Territory Manager (Woundcare)
Cork
Maintenance & Reliability Technician
Limerick
Senior Product Development Engineer
Galway
R&D Engineer
Galway
Senior Process Development Engineer
Galway
Design Assurance Engineer
Galway
Electronic Engineer
Dublin
Director of R&D
Limerick
R&D Manager
Connaught
Principal R&D Engineer
Galway
Engineering Shift Technician
Dublin
Senior Maintenance Technician
Kilkenny
Senior Quality Engineer
Dublin
Senior Regulatory Affairs
Galway
Quality Engineer
Galway
Project Manager
Kildare
Process Engineer
Roscommon
Senior Electronics Engineer
Limerick
R&D Engineer
Galway
Process Engineer
Roscommon
Value Stream Team Leader / Production Su
Wexford
Project Manager (hybrid)
Dublin
Clinical Research Associate
Cork
Quality Assurance Specialist (hybrid)
Dublin
R&D Manager
Galway
Project Manager
Galway
Senior Design Engineer
Dublin
R&D Manager
Connaught
R&D Engineer
Galway
Strategic Automation Lead
Waterford
Product Development Technician II
Galway
CTO
Dublin
Mechanical Engineer
Dublin
Technical Support Specialist - Drug Subs
Louth
Senior R&D Engineer
Galway
Senior R&D Engineer
Galway
Senior Equipment Design Engineer
Dublin
R&D Engineer
Galway
Health & Safety Specialist
Dublin
Senior Regulatroy Affairs Specialsit
Galway
Senior R&D Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Continuous Improvement Coach
Limerick
Principal R&D Engineer
Galway City
CTO
Galway
Quality Engineer
Galway
Senior Mechanical Engineer
Dublin
Design Assurance Engineer
Clare
Clinical Research Manager
Cork
Senior Regulatory Affairs Specialist
Westmeath
Territory Manager (Woundcare) - Dublin -
Dublin
Quality Engineer
Galway
Senior R&D Engineer
Dublin
Regulatory Affairs Specialist
Cork
Director Engineering & Supply Chain
Galway
R&D Manager
Galway
Regulatory Affairs Associate
Cork
Senior R&D Engineer
Galway
Quality Engineer
Galway
Quality Assurance Specialist (Logistics)
Dublin
Senior Regulatory Affairs Specialist
Dublin
Maintenance & Reliability Technician
Limerick
Quality Engineer
Athlone
Quality Engineer
Galway
Injection Moulding Engineer
Leitrim
Senior R&D Engineer
Galway
Tech Transfer Engineer - Drug Product
Republic of Ireland
Senior Quality Engineer
Dublin
Senior R&D Manager
Athlone
R&D Technician II
Galway
Project Manager
Kildare
R&D Program Manager
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
QA Engineer
Leitrim
Senior Electronic Engineer
Dublin
Process Engineer
Roscommon
Senior Engineering Manager
Limerick
R&D Manager
Galway
R&D Director
Galway
Product Development Engineer II
Athlone
Quality Specialist
Tipperary
Electrical Condition Monitoring Technici
Limerick
Design Assurance Program Manager
Galway
Sales/Customer Service Administrator
Clonmel
R&D Manager
Athlone
Injection Moulding Engineer
Athlone
Senior R&D Engineer
Galway
R&D Engineer
Galway
Documentation Specialist
Louth
Senior Regulatory Affairs Specialist
Athlone
Advanced Technologies Manager
Galway
Quality Manager
Galway
R&D Manager
Galway
Senior Associate Quality Control (Shift)
Dublin
Principal Quality Engineer
Galway
Program Manager
Dublin
Senior Quality Engineer
Dublin
Quality Engineer
Athlone
Product Development Manager
Galway
Territory Sales Specialist (Life Science
Belfast City
Product Development Engineer
Dublin
Product Development Engineer
Dublin
Senior Principal Design and Development
Galway
Senior Project Engineer - R&D
Galway
R&D Director
Galway
Principal R&D Engineer
Galway
Principal Engineer
Dublin
Consultant




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

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 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
Subscribe RSS feed for this search

Regulatory Affairs Officer Career Profile

Regulatory Affairs Officer


The Regulatory Affairs (RA) department is tasked with ensuring that the company complies with all of the local and international regulations and laws pertaining to their business. The Regulatory Affairs Officer works with international, state and local regulatory agencies, such as the Irish Medicines Board (IMB), the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) on specific issues affecting their business. The Regulatory Affairs Officer advises the company on the current regulatory aspects and climate that would affect proposed activities. The RA Officer has many interactions within the medical affairs dept. including medical information, pharmacovigilance and clinical trials.

Key responsibilities of the Regulatory Affairs Officer


  • Maintenance of Irish and overseas licenses including preparation of variation and renewal applications as appropriate.
  • Preparation and submission of Marketing Authorisation applications to EU regulatory authorities.
  • Preparation of dossiers to obtain CE marking for medical devices.
  • Ensuring Labelling complies with appropriate legislation.
  • Ensure approved regulatory requirements are enforced in-house.
  • Participate in the development of electronic submission of dossiers.
  • Provide support to R&D projects; including new product introductions, changes to existing products and processes.
  • Liaise with suppliers, clients, development partners and regulatory bodies.
  • Ensure guidelines and knowledge of legislation is current and be able to advise of future developments and changes.
  • Monitor the process of regulatory submissions, responding to queries and ensuring that registration approvals are granted without undue delay.