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 Director
Job Title. Location Salary Actions

Senior Regulatory Affairs Specialist

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. Rep...

Location: Athlone, Clare, Connaught, Galway, Galway City,
Senior Regulatory Affairs Specialist
EU 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

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 Director Career Profile

Regulatory Affairs Director


A strategic role which is responsible for the overall direction of the company, often involved in a smaller company at start-up stage. The spec below refers to an example position in the Medical Device sector

Key Responsibilities

  • Compliance with and adherence to medical device regulations in the geographical areas mentioned.
  • Achieve approval for these 2 products to be sold in new territories, in accordance with Class III Medical Device regulations.
  • Introduce and managed design control and quality systems.
  • Regular meetings with other territories, to collaborate on solutions and current progress. Included in this will be frequent air travel.
  • Dealing directly with relevant local regulatory bodies.
  • Managed Customer Complaints though extensive consultation with physicians and Sales and Marketing personnel.
  • Assisting with research and seeking regulatory approval in relation to possible other clinical indications of the products in various markets.
  • Authored and deliver product presentations to physicians and to sales personnel.
  • Liaise with international colleagues in relation to ongoing clinical monitoring.

Skills / Experience

  • B.Sc. degree in Life Sciences, advanced degree preferred.
  • 10+ years experience in Medical Device Regulatory Affairs, specifically dealing with emerging geographical markets. 4 years in a senior management capacity, preferably internationally.
  • Knowledge of GI / urinary diseases.
Senior Manufacturing Engineer Biotechnology Research Scientist Junior Product Specialist Scientific Research and Development Scientist Product Development Technologist Engineering Manager Biomedical Scientist Research and Development Engineer Process Engineer Senior Project Engineer Supply Chain Specialist Galway City NPD Technologist Contract Biotechnician Product Manager Regulatory Affairs Director Quality Assurance Technologist Dublin City Centre Technical Support Specialist Sligo Supply Chain Coordinator Senior Project Manager Software Engineer Senior Operations Engineer Mechanical Engineer Midlands Project Lead QA Supervisor Quality Specialist Technical Specialist C++ Software Engineer R and D Biochemist Senior Regulatory Affairs Officer Senior Scientist Academic QA Specialist Project Development Engineer QA Executive Clinical Research Life Science Engineering Pharmaceutical Sales Engineer Regulatory Affairs Clinical Research Senior Quality Engineer North Leinster Design Engineer Limerick City Quality Manager Hardware Implementation Engineer Kildare Mayo Software Developer Kilkenny Clare Manufacturing Engineer Medical Device Technical Project Manager Validation Specialist Lead Quality Engineer Consultant (Medical) Systems Analyst Principal Engineer Manufacturing Coordinator Applications Engineer Dublin Greater Principal Research Scientist Process Development Engineer Equipment Engineer Regulatory Affairs Laois Snr R and D Engineer Product Specialist Quality Systems Administator Republic of Ireland Snr Validation Engineer Senior Research and Development Engineer Process Technician Biopharmaceutical Life Science Research and Development Validation Scientist Contract Technical Support BD Manager Quality Assurance QA Manager Supplier Quality Engineer Engineering EHS Engineer Dublin South Regulatory Affairs Manager Electronic Engineer Roscommon Limerick R and D Manager Design Assurance Regulatory Affairs Executive Athlone Regulatory Affairs Specialist Quality Systems Specialist Biomedical Engineer Research and Development Technician Maintenance Technician Lean Team Leader Medical Affairs Quality Control Manager Project Engineer Quality Control Supervisor Validation Engineer Senior Research and Development Scientist Project Manager Dublin North Biotechnology Specialist Research Fellow Galway QA Engineer Academic Programmer R and D Director Dublin Dublin West Product Development Engineer Supply Chain Manager Louth Manufacturing Executive Quality Systems Engineer Longford Controls Engineer Research Engineer Electrical Engineer Regulatory Affairs Consultant Regulatory Affairs Officer Quality Systems Lead Quality Auditor New Product Development Engineer QE Manufacturing Engineer Cork Regulatory Affairs Validation Coordinator Manufacturing and Technology Manager Biotechnologist Connected Health IT Solutions Clinical Project Manager Leinster R & D Technician Principal Scientist QA RA Engineer Quality Engineer Meath QA Validation Specialist Senior Test Engineer Production Engineer Healthcare Validation Manager