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
Engineering Business Manager
Dublin
Senior R&D Engineer
Galway
Process Engineer
Leitrim
Quality Engineer
Galway
Senior Quality Assurance Technical Suppo
Dublin
Senior Director of Manufacturing and Sup
Galway
Sr Project Manager - Syringe Fill Engine
Dublin
Quality Engineer - Supplier
Galway
Senior Quality Assurance Associate
Dublin
Quality Engineer
Athlone
R&D Engineer
Galway
Senior Mechanical Engineer
Dublin
Senior Equipment Design Engineer
Dublin
Senior Reg Affairs Specialist - Post Mar
Galway
Senior Design Assurance Engineer
Galway
Quality Manager
Galway
EHS Specialist II
Limerick
Purchasing & Planning Manager
Wexford
Senior Associate Manufacturing (Investig
Dublin
Senior R&D Engineer
Dublin
Senior Quality Engineer
Leitrim
Senior Electronic Engineer
Dublin
R&D Engineer
Galway
Senior R&D Engineer
Galway
R&D Manager
Galway
R&D Manager
Connaught
Quality Manager
Galway
Senior Quality Engineer
Dublin
Design Assurance Program Manager
Galway
Production Manager
Dublin
Quality Assurance Associate
Cork
Senior Quality Systems Engineer
Galway
QA Engineer
Leitrim
Senior Process Engineer - DP or DS
Dublin
Inside Sales Support & Sourcing Spec
Dublin
NPI Engineer - Hybrid
Dublin
R&D Director
Galway
R&D Engineer
Dublin
R&D Engineer
Galway
Reg Affairs Specialist
Connaught
Associate Quality Specialist
Tipperary
Senior R&D Engineer
Galway
R&D Technician II
Galway
Director of R&D
Limerick
Documentation Specialist
Louth
Principal Design and Development Enginee
Galway
Learning Systems Lead
Limerick
R&D Manager
Galway
Product Development Manager
Galway
Senior Quality Engineer
Leitrim
Quality Engineer
Athlone
Senior Specialist MS&T
Dublin
Senior Electronic Engineer
Dublin
R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Quality Manager
Galway
Principal Engineer
Dublin
R&D Engineer
Galway
Senior Quality Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Quality Manager
Galway
Injection Moulding Engineer
Leitrim
Senior Quality Engineer
Dublin
Senior R&D Engineer
Galway
R&D Engineer
Galway
QA Manager
Canada
Production Operator
Meath
Part time Opportunity-Senior QA Speciali
Dublin
R&D Manager
Dublin
Analytical Chemist
Tipperary
Quality Assurance Specialist (shift)
Carlow
Calibration Technician
Republic of Ireland
Senior Process Engineer - Packaging
Dublin
Senior Design Assurance Engineer
Galway
Quality Assurance Team Lead
Cork
Product Development Engineer
Galway
Senior Quality Engineer
Dublin
R&D Manager
Connaught
Senior Design Engineer
Dublin
Senior R&D Engineer
Clare
Senior Quality Engineer
Galway
Mechanical Technician
Carlow
Key Account Manager - Retail UK National
South East
Senior Electronics Engineer
Limerick
Process Chemist
Limerick
Validation Engineer
Carlow
Validation Engineer
Carlow
Quality Manager
Dublin
Supply Chain Project Manager (hybrid)
Dublin
Design Assurance Manager
Galway
Quality Specialist
Clare
Quality Manager
Dublin
R&D Engineer
Clare
Senior Electronic Engineer
Dublin
Clinical Trial Protocol Specialist
Galway
Sales/Customer Service Administrator
Clonmel
Quality Specialist
Clare
R&D Manager
Galway
Quality Manager - Medical Devices
Limerick City
Responsible Person (RP)
Republic of Ireland
R&D Technician
Galway
Senior Manufacting Engineer
Republic of Ireland
Senior Process Engineer
Dublin
Senior Commissioning & Qualification
Roscommon
Tech Transfer Lead - Sterile Drug Produc
Dublin
Quality Specialist
Tipperary
Senior Principal Design and Development
Galway
R&D Engineer
Galway
R&D Program Manager
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
CTO
Galway
Warehouse Operator
Dublin
Senior Regulatory Affairs Specialist
Athlone
Director of Regulatory Affairs
Galway
Product Development Manager
Galway
Senior Process Engineer
Longford
Quality Assurance Specialist (shift)
Carlow
Product Specialist - Orthopaedic Divisio
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Environmental Health & Safety (EHS)
Longford
Senior Design Assurance Engineer
Galway
Validation & Verification Engineer
Dublin
Injection Moulding Engineer
Athlone
Senior QC Associate - Equipment & I
Dublin
Project Manager
Kildare
Project Manager - New Product Introducti
Dublin
Strategic Automation Lead
Waterford
EHS Specialist II
Limerick
Manufacturing Specialist (Investigation
Dublin
Principal Quality Engineer
Galway
R&D Manager
Galway
Software Design Assurance Engineer
Dublin
R&D Director
Galway
Senior R&D Engineer
Galway
Staff Systems Engineer
Limerick
Advanced Technologies Manager
Galway
Principal Reliability Engineer
Galway
R&D Director
Galway
Senior Project Engineer
Cavan
Project Manager
Kildare
Technical Life Cycle & Engineering M
Galway
Principal R&D Engineer
Dublin
Senior Quality Assurance Specialist (hyb
Dublin
CTO
Dublin
Principal Device Engineer
Dublin
Senior Operations Engineer
Galway
Quality Control Bioassay Specialist
Republic of Ireland
Technical Life Cycle & Engineering M
Galway
Quality Assurance Specialist (Hybrid)
Dublin
QA Quality Systems Specialist
Dublin
Director of R&D
Galway
Senior Regulatory Affairs
Galway
Quality Assurance Senior Specialist
Louth
R&D Manager
Athlone
Senior Process Development Engineer
Dublin
Quality Technician
Dublin
QA Specialist (Investigation Lead)
Dublin
Quality Systems Manager
Dublin
Senior QA Associate (shift)
Dublin
Project Manager (hybrid)
Dublin
Manufacturing Technician
Clare
R&D Senior Program Manager
Galway
Senior Quality Engineer
Dublin
Process Development Engineer
Galway
Product Specialist (Critical Care &
Dublin
R&D Engineer
Galway
Validation Engineer
Republic of Ireland
Senior Product Development Engineer
Galway
Regulatory Affairs Manager - Senior
Galway
R&D Manager
Connaught
R&D Manager
Connaught
Embedded Software Engineer
Dublin
Senior QC Microbiology
Dublin
Product Development Engineer II
Athlone
Operations Engineer
Galway
Quality Technician
Dublin
Manufacturing Specialist - Investigation
Dublin
Industrial Designer
Galway
Principal Engineer
Dublin
Senior Associate Quality Control
Dublin
Regulatory Affairs Maanger
Galway
Senior QC Microbiology
Dublin
Senior Equipment Design Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Senior Project Engineer
Cavan
Lead MSAT Validation Consultant
Republic of Ireland
LIMS Specialist
Tipperary
CAPEX API Project Manager
Tipperary
Principal Design Assurance Engineer
Galway
Sales Manager (Healthcare)
Dublin
Senior Operational Readiness Associate
Dublin
Senior Design Engineer
Dublin
Senior QA Specialist
Dublin
Principal R&D Engineer
Galway
Senior R&D Engineer-New Product Deve
Westmeath
Business Development Manager
Republic of Ireland
Senior Product Development Engineer
Galway
Design Assurance Engineer
Galway
Sr Electrical Engineer
Galway
Purchasing & Planning Manager
Wexford
Senior Regulatory Affairs Specialist
Westmeath
Senior R&D Engineer
Galway
Senior Product Development Engineer
Galway
Principal R&D Engineer
Dublin
Quality Engineer - Supplier
Galway
R&D Manager
Athlone
R&D Engineer
Dublin
Quality Technician
Dublin
Product Development Engineer II
Athlone
R&D Manager
Galway
Senior Human Factors Engineer
Galway
Senior Research & Development Engine
Limerick
Design Quality Engineer
Galway
Application Software Engineer
Galway
Product Specialist (Critical Care &
Dublin
Senior QA Associate (Investigation Lead)
Dublin
R&D Engineer
Galway
Product Development Technician II
Galway
Senior Process Development Engineer
Galway
Senior QC Associate (Bioassay)
Dublin
Injection Moulding Engineer
Athlone
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

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.