I'm looking for...
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
Hot Science Jobs
Process Engineer
Roscommon
Quality Manager - NPI
Dublin
Process Engineer
Roscommon
QA Manager
Canada
Manufacturing Technician
Clare
Senior Quality Engineer
Leitrim
Quality Assurance Engineer
Longford
Quality Engineer
Galway
Quality Manager
Galway
R&D Engineer
Galway
Quality Engineer
Galway
Quality Engineer
Galway
Process Development Engineer
Galway
Design Assurance Program Manager
Galway
Senior R&D Engineer
Galway
Software Design Assurance Engineer
Dublin
Project Manager
Galway
Quality Engineer
Galway
Quality Specialist
Tipperary
Electronic Engineer
Dublin
Senior Equipment Design Engineer
Dublin
Mechanical Technician
Carlow
Project Manager - New Product Introducti
Dublin
Application Software Engineer
Galway
Product Development Engineer
Dublin
Project Manager
Galway
Senior Quality Engineer
Dublin
Health & Safety Specialist
Dublin
Sr Principal R&D Engineer
Galway
Senior R&D Engineer
Clare
Product Development Engineer II
Athlone
Senior Product Development Engineer
Galway
Regulatory Affairs Associate
Cork
Senior R&D Engineer
Galway
Principal Process Equipment Engineer
Dublin South
Learning Systems Lead
Limerick
Process Engineer
Roscommon
Senior Process Engineer
Dublin
Project Manager
Kildare
Senior Electronics Engineer
Dublin
Senior Design Engineer
Dublin
R&D Manager
Galway
Senior Clinical Affairs Specialist (Remo
Republic of Ireland
Senior Clinical Affairs Specialist (Remo
Republic of Ireland
Senior Quality Engineer
Dublin
Documentation Specialist
Louth
Maintenance & Reliability Technician
Limerick
R&D Manager
Connaught
Senior Product Development Engineer
Galway
EHS Officer
Dublin
Principal R&D Engineer
Galway
R&D Engineer
Clare
Senior Quality Assurance Specialist (hyb
Dublin
EHS Officer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Principal R&D Engineer
Galway
Injection Moulding Engineer
Athlone
QA Engineer
Leitrim
Electronic Engineering
Dublin
Manufacturing Engineer
Galway
R&D Engineer
Galway
Technical Support Specialist - Drug Subs
Louth
Quality Assurance Specialist (Logistics)
Dublin
Senior Reg Affairs Specialist - Post Mar
Galway
Senior Regulatory Affairs Specialist
Athlone
Validation & Verification Engineer
Dublin
Quality Specialist
Clare
Regulatory Affairs Manager - Senior
Galway
Senior Product Development Engineer
Galway
Process Engineer
Galway
Senior Operations Engineer
Galway
Warehouse Operator
Meath
Senior R&D Engineer
Dublin
Senior Manufacting Engineer
Republic of Ireland
Engineering Shift Technician
Dublin
CTO
Dublin
Director of R&D
Limerick
Regulatory Affairs Manager - Senior
Galway
R&D Manager
Connaught
Business Development Representative-Cali
Republic of Ireland
Senior Maintenance Technician
Kilkenny
Senior Equipment Design Engineer
Dublin
Senior R&D Engineer
Galway
Responsible Person (RP)
Republic of Ireland
Senior Quality Engineer
Dublin
Quality Technician
Dublin
Electronic Engineer
Dublin
Project Manager - R&D
Galway
Senior Quality Systems Engineer
Galway
Sales/Customer Service Administrator
Clonmel
Manufacturing Technician
Clare
Senior Project Engineer
Cavan
Sr Electrical Engineer
Galway
Senior Design Engineer
Dublin
Operations Engineer
Galway
R&D Engineer
Galway
Documentation Specialist
Louth
Director of R&D
Clare
Senior Research and Development Engineer
Galway
Director of R&D
Limerick
Senior Quality Engineer
Leitrim
Senior Design Assurance Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Product Development Engineer II
Athlone
R&D Manager
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Value Stream Team Leader / Production Su
Wexford
Senior Manufacturing Engineer
Galway
Project Manager
Galway
Quality Engineer
Galway
R&D Director
Galway
Principal Engineer
Dublin
Sr Electrical Engineer
Galway
Purchasing & Planning Manager
Wexford
Strategic Automation Lead
Waterford
Manufacturing Technician
Clare
Documentation Specialist
Louth
Senior Regulatory Affairs Specialist
Athlone
Injection Moulding Engineer
Athlone
Quality Technician
Dublin
Director of R&D
Limerick
Product Development Engineer
Galway
Technical Life Cycle & Engineering M
Galway
Senior R&D Manager
Athlone
(Senior) Manufacturing Engineers - Globa
Limerick
Director of Quality Engineering
Limerick
Senior R&D Engineer
Galway
Warehouse Operator
Meath
Injection Molding Engineer
North Leinster
Technical Life Cycle & Engineering M
Galway
Project Manager
Kildare
Director of Regulatory Affairs
Galway
Design Assurance Program Manager
Galway
R&D Director
Galway
Sourcing Specialist
Tipperary
Electronic Engineer
Dublin
R&D Engineer
Dublin
Quality Engineer
Galway
R&D Manager
Connaught
Documentation Specialist
Louth
R&D Director
Galway
Senior Quality Engineer
Dublin
Senior R&D Engineer II
Galway
Program Manager
Dublin
R&D Manager
Galway
Senior Quality Engineer
Dublin
Design Assurance Engineer
Clare
Product Development Engineer
Dublin
Manufacturing Technician
Galway
Senior R&D Engineer
Galway
Process Engineer
Roscommon
Senior Maintenance Technician
Roscommon
Project Manager - R&D
Galway
Senior R&D Engineer
Galway
R&D Engineer
Galway
Product Development Engineer
Galway
Senior Process Engineer
Longford
R&D Manager
Connaught
Design Quality Engineer
Galway
Senior Associate Quality Control (Shift)
Dublin
Process Chemist
Limerick
Design Assurance Engineer
Clare
Senior R&D Engineer
Galway
R&D Engineer
Galway
Project Manager Design Assurance
Galway
Senior Electronic Engineer
Dublin
Senior Regulatroy Affairs Specialsit
Galway
R&D Manager
Dublin
Senior Regulatory Affairs Specialist
Athlone
Project Manager
Galway
Principal R&D Engineer
Galway
R&D Engineer
Dublin
Staff Systems Engineer
Limerick
Senior Engineering Manager
Limerick
Clinical Research Associate
Cork
R&D Engineer
Galway
Senior R&D Engineer
Galway
Calibration Technician
Republic of Ireland
Senior R&D Engineer
Galway
CTO
Galway
Staff R&D Engineer
Limerick
Senior Process Engineer
Galway
R&D Engineer
Galway
Regulatory Affairs Associate
Cork
R&D Manager
Athlone
Principal Reliability Engineer
Galway
R&D Engineer
Galway
Mechanical Engineer
Dublin
Purchasing & Planning Manager
Wexford
Engineering Support Specialist
Louth
Senior Clinical Affairs Specialist (Remo
Republic of Ireland
Engineering Business Manager
Dublin
Senior Project Engineer
Cavan
Senior Quality Engineer
Dublin
Manufacturing Technician
Clare
R&D Manager
Athlone
Senior Regulatory Affairs Specialist
Dublin
R&D Manager
Galway
Quality Manager - Medical Devices
Limerick City
Senior Manufacturing Engineer
Galway City
Senior Equipment Design Engineer
Dublin
Principal R&D Engineer
Dublin
Production Manager
Dublin
Project Manager - R&D
Galway
Quality Assurance Specialist (hybrid)
Dublin
Shift Technician (Injection Moulding)
Kildare
Technical Marketing Manager
Wexford
Senior QC Associate
Dublin
R&D Engineer
Galway
R&D Manager
Galway
Principal Instrumentation & Calibrat
Limerick
R&D Engineer
Galway
Product Development Technician II
Galway
Quality Engineer
Wexford
Validation Engineer
Athlone
Business Development Manager (Pharma &am
Republic of Ireland
Senior Principal Design and Development
Galway
Consultant




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

Senior Regulatory Affairs Manager

Job title: Sr Regulatory Affairs Manager Location: Mervue, Galway Benefits: Top salary, bonus, pension, healthcare and car allowance Overview: As the Senior Manager of Regulatory Affairs, you play a key leadership role within the Acute Care & Monitoring (ACM) operating unit, supporting regulatory activities for a portfolio of products. This role entails implementing regulatory strategies, managing regulatory submissions, assessing the regulatory impact of product changes, and ensuring your team delivers high-quality results...

Location: Galway, Galway City,
Senior Regulatory Affairs Manager 		Galway Not Disclosed

Regulatory Affairs Manager - Senior

Job title: Sr Regulatory Affairs Manager Location: Mervue, Galway Benefits: Top salary, bonus, pension, healthcare and car allowance Overview: As the Senior Manager of Regulatory Affairs, you play a key leadership role within the Acute Care & Monitoring (ACM) operating unit, supporting regulatory activities for a portfolio of products. This role entails implementing regulatory strategies, managing regulatory submissions, assessing the regulatory impact of product changes, and ensuring your team delivers high-quality results...

Location: Galway, Galway City,
Regulatory Affairs Manager - Senior 		Galway Not Disclosed

Regulatory Affairs Manager - Senior

Job title: Sr Regulatory Affairs Manager Location: Mervue, Galway Benefits: Top salary, bonus, pension, healthcare and car allowance Overview: As the Senior Manager of Regulatory Affairs, you play a key leadership role within the Acute Care & Monitoring (ACM) operating unit, supporting regulatory activities for a portfolio of products. This role entails implementing regulatory strategies, managing regulatory submissions, assessing the regulatory impact of product changes, and ensuring your team delivers high-quality results...

Location: Galway, Galway City,
Regulatory Affairs Manager - Senior 		Galway Not Disclosed

Regulatory Affairs Manager - Senior

Job title: Sr Regulatory Affairs Manager Location: Mervue, Galway Benefits: Top salary, bonus, pension, healthcare and car allowance Overview: As the Senior Manager of Regulatory Affairs, you play a key leadership role within the Acute Care & Monitoring (ACM) operating unit, supporting regulatory activities for a portfolio of products. This role entails implementing regulatory strategies, managing regulatory submissions, assessing the regulatory impact of product changes, and ensuring your team delivers high-quality results...

Location: Galway, Galway City,
Regulatory Affairs Manager - Senior 		Galway Not Disclosed

Regulatory Specialist

Title: Regulatory Specialist Location: Galway business park, Galway Benefits: Salary, bonus, pension, hybrid working and healthcare Overview: As a Regulatory Specialist you will support the commercialisation of Medical Device products. This includes preparation and submission of regulatory filings for product market entry, as well as regulatory activities required for the maintenance of existing commercial products. The position requires a high level of innovative thought and problem-solving skills. In order to coordinate the variety of regulatory related task...

Location: Galway, Galway City,
Regulatory Specialist 		Galway Not Disclosed

Reg Affairs Specialist

Role: Regulatory Affairs Engineer Location: Parkmore, Galway (Hybrid working) Benefits: Top salary Company: My client are a growing Medical Device company who have recently moved into a high tech new site in Parkmore. They have developed an innovative new technology to improve the performance of Vascular stents. Role: Reporting to the Senior Regulatory Affairs Manager, as a Regulatory Affairs Specialist you will play a key a key role in the implementation of post-market activities within Veryan. This is a ...

Location: Connaught, Galway, Galway City, Leitrim, Limerick,
Reg Affairs Specialist 		EU Not Disclosed

Senior Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist Location: Parkmore, Galway. 1 day 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 the Se...

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

Senior Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist Location: Parkmore, Galway. 1 day 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 the Se...

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

Senior Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist Location: Parkmore, Galway. 1 day 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 the Se...

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

Senior Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist 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 the Senior Reg...

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

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 Specialist

Regulatory Affairs Specialist (Remote/Hybrid) Our client a high potential start up medical device company currently seeks a Regulatory Affairs Specialist to join their team. Reporting to the Clinical and Regulatory Affairs Manager, the Regulatory Specialist will be responsible for helping with compliance to standards, regulatory submissions and annual reporting to the notified body and FDA. The Regulatory Affairs Specialist must have a working knowledge of medical device regulatory requirements and standard practices in the medical device industry. This position re...

Location: Cork,
Regulatory Affairs Specialist 		Cork Not Disclosed
Subscribe RSS feed for this search

Regulatory Affairs Executive Career Profile

Regulatory Affairs Executive

The role concerns the filing and regulatory maintenance of Biopharmaceutical drug products. Depending on the company and the market authorisations for various drugs, Reg Affairs professionals will be required to deal with the IMB (Irish Medicines Board), MHRA (Medicines and Healthcare products regulatory Authority - UK) and FDA (Food & Drug Administration - US)

Responsibilities


  • Life cycle management and Maintenance of regulatory filings including annual reports and supplements to US FDA.
  • Preparation of registration submissions, in CTD (Clinical Trial Dossier) format, for biopharmaceutical products for approval by the US FDA, European Regulatory Authorities and worldwide, as required.
  • Monitoring the progress of registration submissions, responding to queries and ensuring that registration approvals are granted without undue delays.
  • Regulatory Compliance, for change control activities monitoring the impact of changes in regulatory submissions.
  • Monitoring adverse events for submissions, preparation and review and generation of supporting documents for potential field alerts and recalls.
  • Maintenance of approvals, including the preparation of annual reports for US products.
  • Assess and review documentation to ensure compliance with product licences.
  • Undertake general regulatory activities that interface with other departments such as Manufacturing, Product Development, Quality Control and Quality Assurance.
  • Actively participate in project teams, as required.

Qualifications / Experience

  • Minimum of 3 years regulatory experience in the pharmaceutical industry.
  • Knowledge of the current regulatory requirements, particularly US and EU.
  • Experience in writing and submitting regulatory documentation.