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
Validation and Verification Engineer
Dublin
Distribution Centre Manager
Dublin
Associate Director Clinical Trial Capabi
Cork
Staff R&D Engineer- Customer Focus
Dublin
Maintenance Reliability Engineer
Cork
Senior Associate QA (24/7 Shift)
Dublin
Quality Specialist
Tipperary
R&D Manager
Galway
R&D Manager
Galway
Senior Validation Engineer
Limerick
QC Micro Analyst (shift)
Cork
Senior R&D Engineer
Clare
Senior E&I Maintenance Technician
Carlow
Technical Transfer Engineer - Drug Subst
Louth
Senior Recruitment Consultant
Dublin
Clean Utilities Engineer
Cork
Senior Quality Engineer
Galway
Senior Human Factors Engineer
Dublin
Commissioning and Qualification Engineer
Cork
Lead Maintenance Reliability Engineer
Westmeath
QC Analyst
Meath
Senior Project Equipment Engineer
Dublin
Regional Procurement Senior Specialist (
Dublin
Recruitment Consultant
Wexford
Change Control Coordinator
Carlow
Facilities Engineer
Carlow
Manager/ Senior Manager Drug Product Man
Republic of Ireland
Project Manager
Limerick
Manufacturing Process Owner Lead
Dublin
Senior Quality Engineer
Dublin
C&Q Lead
Tipperary
Project Engineer
Republic of Ireland
Senior Project Engineer
Cork
Principal Process Equipment Engineer
Dublin South
Associate QA Specialist (Shift)
Carlow
Clean Utilities Engineer
Carlow
Project Process Engineer
Carlow
Maintenance Reliability Engineer
Tipperary
Senior Principal Statistician(Clinical T
Cork
Lead Maintenance Reliability Engineer
Westmeath
EHS Systems Specialist
Dublin
Senior R&D Engineer - Controls syste
Galway
Senior Associate Quality Operations
Limerick
Product Development Engineer
Galway
Technical Sales Specialist (Cell Biology
Dublin
Senior Associate Quality Control NPI
Dublin
Technical Engineer - Process Simulation
Carlow
Manufacturing Engineer
Wexford
Digital Lab Records Specialist
Tipperary
Project Manager - Capital Projects
Cork
Manufacturing Engineer
Galway
Chemist - mAbs Reviewer
Cork
QA Associate Specialist
Carlow
Product Specialist (Orthopaedic) - Dubli
Dublin
E&I Turnover Engineer
Carlow
Senior Technical Scientist - Technical T
Cork
QC Bioanalytical Analyst
Dublin
Senior R&D Project Manager
Galway
Strategic Automation Lead
Waterford
R&D Manager
Galway
Quality Specialist - Remediation
Louth
Project Engineer
Limerick
Senior Quality Engineer
Dublin
Aseptic Process Lead
Carlow
Technical Transfer Specialist - Remote
Republic of Ireland
Pharmaceutical Operator
Louth
QC Laboratory Technician
Carlow
Engineering Business Manager
Dublin
Product Development Engineer
Galway
Senior Regulatory Affairs Specialist
Dublin
Qualified Person
Limerick
Technical Specialist (Chemistry - Leinst
Dublin
R&D Director
Galway
R&D Senior Program Manager
Galway
Manufacturing Process Specialist
Cork
Senior EHS Specialist
Louth
R&D Manager
Galway
Quality Manager - NPI
Dublin
Senior Project Manager - Electrical
Dublin
Biomedical Engineer
Dublin
Clinical SAS Programmer
Cork
Principal Heart Valves Engineer
Galway
EHS Systems Specialist
Carlow
Associate Quality Specialist
Tipperary
Project Engineer
Tipperary
Maintenance CMMS Engineer
Tipperary
Electrical and Instrumentation Turnover
Carlow
Senior Recruitment Consultant
Republic of Ireland
Principal R&D Engineer
Dublin
Senior Technical Writer
Dublin
Design Assurance Supervisor
Mayo
EHS Project Lead
Cavan
Responsible Person (RP)
Republic of Ireland
Senior Validation Engineer
Dublin
Validation Specialist - 50/50 remote
Carlow
Medical Device Director
Republic of Ireland
Senior Regulatroy Affairs Specialsit
Galway
Associate Quality Specialist
Tipperary
Maintenance Engineer
Carlow
Senior Product Development Engineer
Galway
Technical Transfer Specialist
Cork
R&D Director
Galway
Customer Service Administrator
Dublin
Regional Service Manager (East)
Dublin
Suite Team Delivery Lead
Tipperary
Cleaning Validation Specialist
Cork
Manufacturing Engineer
Galway
Senior R&D Engineer-New Product Deve
Westmeath
Process Engineer
Limerick
Senior Reg Affairs Specialist - Post Mar
Galway
Quality Technician
Dublin
Recruitment Consultant
Republic of Ireland
Sales/Customer Service Administrator
Clonmel
Head of R&D
Galway
Documentation Specialist
Cork
Graduate Laboratory Technician
Republic of Ireland
Senior Manufacting Engineer
Republic of Ireland
Quality Engineer
Galway
Validation Specialist
Cork
Chemical Engineer
Tipperary
Procurement Senior Specialist
Meath
(Senior) Manufacturing Engineers - Globa
Limerick
Process Validation Engineer
Cork
Senior Recruitment Consultant
Republic of Ireland
QA Specialist (hybrid)
Cork
QC Bioassay Analyst (shift)
Carlow
R&D Engineer
Dublin
Quality Technician
Dublin
Production Operator
Carlow
Process Engineer
Cork
Trainer
Dublin
Senior Quality Engineer
Dublin
Product Specialist (Orthopaedic Recon -
Galway
Senior Quality Engineer-Remote
Republic of Ireland
Project Manager - Suite Lead
Tipperary
QC Laboratory Technician (shift)
Carlow
Technical Transfer Specialist - Remote
Republic of Ireland
Aseptic Process Lead
Carlow
Product Specialist - Primary Care Divisi
Cavan
Engineering Projects Lead
Carlow
Quality Manager - NPI
Dublin
Regulatory Affairs Specialist
Cork
Project Manager - R&D
Galway
Associate Quality Specialist
Cork
Senior QC 24/7 Shift
Dublin
Validation Engineer
Cork
QC Laboratory Technician Shift (Incoming
Carlow
Process Engineer
Galway
Clinical Affairs Manager
Galway
Principal/Senior R&D Engineer Cathet
Galway
Quality Management System Specialist
Cork
Senior Engineering Manager
Limerick
CQV Lead
Tipperary
Senior Process Enginer
Dublin South
Senior R&D Engineer
Dublin
Regional Program Coordinator - Global Le
Dublin
Sourcing Specialist
Tipperary
R&D Director
Galway
BMS Senior Automation Engineer
Louth
Quality Manager
Dublin
Manufacturing Project Engineer
Sligo
Senior R&D Engineer
Galway
Technology Transfer Specialist (Technica
Cork
Process Support Specialist
Carlow
German Customer Excellence and Medical S
Cork
Senior Project Manager - Process Develop
Dublin South
Production Operator
Carlow
E&I Maintenance Technician - 4 cycle
Carlow
Consultant




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

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.