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

Associate / Sr Associate (Regulatory Labelling)

Associate / Sr Associate - Regulatory Labelling Our client is a global healthcare leader. Their employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. They are looking for people who are determined to make life better for people around the world. For more than 140 years, they have worked tirelessly to discover medicines that make life better. They are currently seeking a Labelling Associate / Senior Labeling...

Location: Cork,
Associate / Sr Associate (Regulatory Labelling)
Cork 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

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