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 Process Development Engineer
Galway
Project Manager - R&D
Galway
Senior Tech Transfer Specialist
Meath
R&D Engineer
Galway
Site Microbiologist
Republic of Ireland
R&D Engineer
Galway
Principal Scientist/Engineer Medical Dev
Dublin
Responsible Person (RP)
Republic of Ireland
Purchasing & Planning Manager
Wexford
Product Development Engineer II
Athlone
Principal R&D Engineer
Galway
Product Development Engineer
Dublin
Quality Technician
Dublin
Injection Molding Engineer
North Leinster
Principal Software Engineer
Athlone
Injection Molding Engineer
North Leinster
R&D Manager
Galway
Project Manager
Galway
R&D Manager
Connaught
R&D Director
Galway
Senior Project Engineer
Cavan
R&D Director
Galway
Documentation Specialist
Louth
Calibration Technician
Republic of Ireland
Associate Director - Manufacturing &
Limerick
Senior R&D Engineer
Galway
R&D Engineer
Dublin
R&D Engineer
Galway
Electronic Engineer
Dublin
Project Manager
Kildare
Principal R&D Engineer
Dublin
Senior Electronic Engineer
Dublin
R&D Manager
Galway
Validation Engineer
Athlone
Senior R&D Engineer
Dublin
Senior Process Engineer
Dublin
Principal Process Equipment Engineer
Dublin South
Senior R&D Engineer
Clare
R&D Manager
Galway
Technical Specialist (Hybrid)
Cork
Senior Recruitment Consultant
Republic of Ireland
Senior Regulatory Affairs Specialist
Athlone
Manufacturing Engineer
Cork
Senior Project Engineer
Cavan
Process Engineer - MS&T (Hybrid)
Dublin
Reliability Engineering Consultant - Rem
Republic of Ireland
Electronic Engineer
Dublin
Senior Quality Systems Engineer
Galway
R&D Engineer
Galway
Quality Manager - NPI
Dublin
R&D Director
Galway
Senior Equipment Design Engineer
Dublin
Quality Control Analyst (shift)
Carlow
Production Manager
Dublin
R&D Engineer
Galway
Product Development Engineer
Galway
Senior Quality Engineer
Leitrim
Principal Quality Engineer
Galway
Reg Affairs Specialist
Connaught
Product Development Technician II
Galway
Project Manager - R&D
Galway
R&D Manager
Connaught
Project Engineer
Cork
Associate Director Site Data Integrity L
Limerick
Associate Analytical Scientist
Meath
R&D Engineer
Galway
Senior Electronic Engineer - Regulated M
Galway
QA Engineer
Leitrim
CTO
Galway
Senior Electronic Engineer
Dublin
Senior R&D Engineer
Galway
R&D Manager
Athlone
Quality Technician
Dublin
Senior Manufacturing Engineer
Galway
R&D Manager
Connaught
Senior Design Engineer
Dublin
R&D Manager
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Maintenance & Reliability Technician
Limerick
Biomedical Engineer
Dublin
Cleaning Validation Specialist
Cork
Senior Technical Transfer Specialist
Cork
Senior Regulatory Affairs Specialist
Athlone
Manufacturing Engineer
Cork
Manufacturing Project Engineer
Mayo
Manufacturing Project Engineer
Sligo
Senior Quality Engineer
Dublin
Senior R&D Engineer
Galway
Quality Technical Services Manager - 12
Dublin
Quality Engineer
Galway
Senior Associate Quality Control
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Microbiology Manager
Dublin
Regulatory Affairs Specialist
Cork
Maintenance CMMS Engineer
Tipperary
Senior Microbiologist
Dublin
R&D Manager
Athlone
Senior R&D Engineer
Galway
Electronic Engineer
Dublin
Director of Regulatory Affairs
Galway
Quality Manager
Galway
Senior Manufacting Engineer
Republic of Ireland
Senior R&D Engineer
Galway
Quality Specialist
Tipperary
Project Manager (hybrid)
Dublin
Product Development Engineer
Dublin
Electrical Condition Monitoring Technici
Limerick
R&D Manager
Galway
Manufacturing Engineer
Wexford
Senior Design Engineer
Dublin
Senior Quality Engineer
Dublin
R&D Engineer
Dublin
Quality Engineer
Galway
Quality Assurance Senior Specialist
Louth
Team Leader - Lab Services
Dublin
Senior Quality Engineer
Leitrim
Engineering Support Specialist
Louth
Program Manager
Dublin
Procurement Associate
Dublin
Senior Equipment Design Engineer
Dublin
Operational Excellence Specialist
Cork
Lead Chemistry Analyst
Cork
Principal R&D Engineer
Dublin
Injection Molding Engineer
North Leinster
Senior R&D Engineer
Dublin
Injection Molding Engineer
North Leinster
Quality Assurance Specialist (hybrid)
Dublin
Product Development Engineer
Galway
E&I Turnover Engineer
Carlow
Business Manager (Woundcare, Orthopaedic
Dublin
Senior Operations Engineer
Galway
Senior Associate Quality Control (Shift)
Dublin
R&D Engineer
Galway
Quality Engineer
Galway
Senior R&D Engineer - Sustaining
Galway
Senior Mechanical Engineer
Dublin
R&D Engineer
Clare
Project Engineer
Limerick
Quality Specialist & Deputy RP
Limerick
R&D Manager
Galway
Senior Quality Engineer
Dublin
Design Assurance Engineer
Galway
R&D Engineer
Galway
Senior Quality Systems Engineer
Galway
Design Assurance Engineer
Clare
Senior Regulatory Specialist
Cork
Manufacturing Technician
Clare
Mechanical Technician
Carlow
Senior Recruitment Consultant
Republic of Ireland
Quality Systems Manager
Dublin
Electronic Engineering
Dublin
Senior Research and Development Engineer
Galway
Senior R&D Engineer
Galway
Analytical Scientist
Meath
R&D Engineer
Galway
Maintenance Reliability Engineer
Cork
Principal Engineer
Dublin
Injection Moulding Engineer
Athlone
Principal Device Engineer
Dublin
R&D Manager
Connaught
Engineering Shift Technician
Dublin
Senior Regulatory Affairs Specialist
Dublin
Senior Regulatory Affairs Specialist
Athlone
Principal Engineer
Dublin
R&D Senior Program Manager
Galway
Process Chemist
Limerick
Quality Engineer
Galway
Principal R&D Engineer
Galway
Project Manager
Louth
Quality Specialist
Clare
R&D Director
Galway
DeltaV Lead Automation Engineer
Tipperary
Design Assurance Program Manager
Galway
Senior Regulatory Affairs Specialist
Athlone
Quality Engineer
Galway
MS&T Bioprocess Engineer
Meath
Product Development Engineer
Dublin
Quality Engineer
Galway
Senior R&D Engineer-New Product Deve
Westmeath
QA Manager
Canada
Warehouse Operator
Meath
Quality Manager - Medical Devices
Limerick City
CTO
Dublin
Quality Engineer
Galway
Project Manager
Kildare
R&D Engineer
Galway
Shift Technician (Injection Moulding)
Kildare
DeltaV Technical Coordinator - Hybrid
Tipperary
Lead Maintenance Reliability Engineer
Westmeath
Senior Electronic Engineer
Dublin
Senior Quality Engineer
Dublin
Senior Quality Engineer
Leitrim
Senior Validation Engineer
Dublin
Technical Life Cycle & Engineering M
Galway
Project Engineer
Clare
Senior Principal Design and Development
Galway
Senior R&D Engineer
Galway
Principal R&D Engineer
Galway
Electronic Engineer
Dublin
Quality Manager
Dublin
CAPA Specialist
Cavan
Senior Equipment Engineer
Dublin
Senior R&D Engineer - Sustaining
Galway
Production & Logistics Planner
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Senior R&D Engineer
Dublin
Senior Maintenance Technician
Roscommon
Senior Regulatory Affairs Specialist
Athlone
Senior R&D Engineer
Galway
Change Control SME
Cork
Sales/Customer Service Administrator
Clonmel
Senior Engineering Manager
Limerick
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.