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
Alert

Sorry
There are no Open Vacancies that Match your Search

Other similar job titles you may be intertested in include: Compliance Specialist Regulatory Affairs Manager

Please view a sample career profile in the box below
or click here to browse all open vacancies

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.
Senior Research and Development Scientist Validation Engineer Kildare QE Manufacturing Engineer R and D Manager Principal Research Scientist Snr R and D Engineer Academic Louth Senior Project Engineer Galway Quality Auditor Process Technician Software Developer QA Validation Specialist Biotechnologist Clare Equipment Engineer Dublin Greater Healthcare Sales Engineer QA Specialist Product Development Technologist Senior Quality Engineer Life Science Quality Specialist Pharmaceutical Quality Systems Lead Supply Chain Manager Production Engineer Life Science Research Engineer Design Assurance Limerick Supplier Quality Engineer Biomedical Engineer Dublin South Biomedical Scientist Snr Validation Engineer Quality Systems Engineer Product Manager Laois Republic of Ireland Validation Scientist NPD Technologist R & D Technician Quality Control Supervisor Validation Manager Software Engineer Quality Control Manager Quality Systems Specialist Product Development Engineer Biotechnology Specialist Research and Development Scientist Technical Support Maintenance Technician Midlands Manufacturing Engineer R and D Biochemist QA Engineer Design Engineer Project Manager Project Development Engineer Senior Manufacturing Engineer Research and Development Engineer Hardware Implementation Engineer Research and Development Connected Health Programmer Postdoctoral Research Fellowship Supply Chain Specialist BD Manager Mechanical Engineer Lean Team Leader EHS Engineer Senior Project Manager Biopharmaceutical Dublin Technical Support Specialist Quality Assurance Technologist Product Specialist QA Executive Electrical Engineer Longford Senior Scientist QA Manager Biotechnician Dublin City Centre Manufacturing and Technology Manager Clinical Research Quality Assurance Kilkenny Engineering Principal Scientist Galway City Dublin West Scientific Academic Senior Research and Development Engineer Engineering Biotechnology Systems Analyst Electronic Engineer New Product Development Engineer Manufacturing Coordinator Process Engineer Limerick City Research and Development Technician Quality Manager Senior Operations Engineer Medical Affairs Technical Specialist Research Fellow Leinster Meath Applications Engineer Technical Project Manager Validation Specialist Process Development Engineer Supply Chain Coordinator Dublin North Engineering Manager Research Scientist QA RA Engineer Project Engineer Lead Quality Engineer Project Lead Quality Engineer Principal Engineer Medical Device Regulatory Affairs Manufacturing Executive QA Supervisor