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 Consultant
Job Title. Location Salary Actions

Senior Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist – Premarket Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Company: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. This role is best suited to an individual who is self-motivated, accountable and seeking infinite learning and growth opportunities. Role: As a Senior Regulatory Affairs Specialist you will will pl...

Location: Clare, Connaught, Galway, Galway City, Limerick,
Senior Regulatory Affairs Specialist
EU Not Disclosed

Regulatory Affairs Consultant Career Profile

Regulatory Affairs Consultant


Whether it's working in a solo-operation, or in a Regulatory Consultancy, working as a consultant can give flexibility and great challenges to a Regulatory expert with a number of years in industry.

Key Responsibilities

  • Timely preparation and submission variations and renewal applications for National and MRP procedures to the IMB, MHRA and other regulatory authorities.
  • Provide responses to the competent authorities on deficiencies where they arise.
  • Review and update of summary of product characteristics and patient information leaflets as required.
  • Provide guidance and support regarding regulatory requirements as requested by clients.
  • Preparation of clinical trial submissions to various regulatory authorities.
  • Quality Control review of submission documentation prior to relevant competent authorities.
  • Perform internal audits & self-inspections to ISO 9000:2008 standard.
  • Participation in business development/marketing activities.

Skills / Experience

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