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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.
Regulatory Affairs Manager Senior Research and Development Engineer Sligo Biotechnology Specialist Hardware Implementation Engineer Quality Specialist Project Lead Principal Scientist Regulatory Affairs Director Project Manager Connected Health QE Manufacturing Engineer Clinical Research Nurse Validation Coordinator Product Development Engineer Leinster Cork Validation Engineer Medical Device Scientific Manufacturing Engineer Technical Support Specialist Principal Engineer Regulatory Affairs Officer Regulatory Affairs Clinical Research Process Development Engineer Project Engineer Process Technician Life Science Healthcare Quality Manager Limerick City Quality Control Manager QA RA Engineer Process Engineer Kildare Lead Quality Engineer Clinical Project Manager Junior Product Specialist Academic Regulatory Affairs Consultant R & D Technician Dublin City Centre Design Engineer Snr Validation Engineer New Product Development Engineer NPD Technologist Validation Specialist Regulatory Affairs EHS Engineer Dublin South Senior Manufacturing Engineer Quality Engineer Electrical Engineer QA Engineer Consultant (Medical) Regulatory Affairs Senior Research and Development Scientist Dublin Senior Operations Engineer Project Development Engineer Technical Project Manager Quality Systems Specialist Clinical Trials Advisor R and D Director Pharmaceutical Research and Development Scientist Clinical Research Associate Life Science Clare Quality Control Supervisor Quality Systems Engineer Validation Scientist R and D Biochemist QA Supervisor Biomedical Engineer North Leinster Roscommon Regulatory Affairs Executive Dublin West Product Manager Sales Engineer Galway City Research Engineer Applications Engineer Senior Project Engineer QA Manager QA Specialist Galway Research Scientist Biotechnology Snr R and D Engineer Technical Support Product Specialist Mechanical Engineer Quality Assurance Dublin North Engineering Manager Engineering Engineering Research and Development Technical Specialist QA Executive Dublin Greater Medical Affairs Design Assurance Athlone Research and Development Engineer Research Fellow Supplier Quality Engineer Clinical Research QA Validation Specialist Product Development Technologist Senior Scientist Senior Quality Engineer Electronic Engineer Regulatory Affairs Specialist Limerick BD Manager Biopharmaceutical Meath Biomedical Scientist Senior Project Manager Senior Regulatory Affairs Officer R and D Manager Principal Research Scientist Research and Development Technician Academic Quality Systems Lead Laois