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
R&D Director
Galway
Regulatory Affairs Specialist
Cork
Cleaning Validation Specialist
Cork
R&D Engineer
Galway
Staff R&D Engineer
Limerick
Senior Design Engineer
Dublin
Senior Mechanical Engineer
Dublin
Process Engineer
Carlow
R&D Director
Galway
Quality Systems Specialist
Tipperary
R&D Manager
Galway
Senior Engineering Manager
Limerick
Pharmacovigilance Manager (Remote)
Republic of Ireland
R&D Engineer
Galway
Biostatistician
Dublin City Centre
Account Manager (Chemicals) - Dublin
Dublin
Senior R&D Manager
Athlone
Senior R&D Engineer
Clare
Associate Director Site Data Integrity L
Limerick
Engineering Projects Lead
Carlow
Project Manager - Tech Transfer
Louth
Product Development Engineer II
Athlone
Manufacturing Engineer
Galway
Principal Engineer
Dublin
Quality Specialist
Clare
Electronic Engineer
Dublin
Clinical Project Manager
Cork
Quality Technical Services Manager - 12
Dublin
R&D Engineer
Galway
Quality Engineer
Galway
Graduate Manufacturing Technician
Kilkenny
Responsible Person (RP)
Republic of Ireland
Senior Quality Engineer
Dublin
Senior Research & Development Engine
Limerick
Product Development Engineer
Galway
R&D Engineer
Galway
Senior Design Assurance Engineer
Athlone
Senior R&D Engineer
Dublin
Senior Quality Engineer
Dublin
Senior Procurement Associate
Limerick
Program Manager
Dublin
R&D Manager
Athlone
Scientific Writer Publications
Cork
Senior Equipment Design Engineer
Dublin
Injection Moulding Engineer
Athlone
Regional Program Coordinator - Global Le
Dublin
Design Assurance Engineer
Galway
Manufacturing Project Engineer
Sligo
Senior Quality Control Associate
Dublin South
Senior Regulatory Affairs
Galway
Senior R&D Engineer - Lifecycle Mana
Galway
R&D Engineer
Galway
Validation Specialist - 50/50 remote
Carlow
Quality Engineer
Galway
Sales/Customer Service Administrator
Clonmel
Product Development Manager
Galway
Principal R&D Engineer
Dublin
Senior R&D Engineer
Galway
Principal Engineer
Dublin
Principal Process Development Engineer
Dublin
Senior Quality Engineer
Leitrim
R&D Manager
Connaught
Quality Engineer
Galway
Injection Molding Engineer
North Leinster
Quality Engineer
Wexford
Change Control SME
Cork
Senior Reg Affairs Specialist - Post Mar
Galway
DeltaV Technical Coordinator - Hybrid
Tipperary
Electrical Project Engineer
Cork
Associate QA Specialist (Shift)
Carlow
Cleaning Validation Specialist
Cork
Scientific Writer Regulatory
Cork
Utilities Engineer
Dublin
Senior Quality Engineer-Remote
Republic of Ireland
R&D Engineer
Galway
CTO
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Process Support Specialist
Carlow
Project Manager
Louth
Account Manager UK and Ireland
Republic of Ireland
R&D Senior Program Manager
Galway
R&D Manager
Galway
Senior Electrical Engineer
Galway
R&D Manager
Connaught
Project Manager - R&D
Galway
Project Manager
Kildare
QA Manager
Canada
R&D Engineer
Galway
EHS Systems Specialist
Dublin
Manufacturing Technician
Clare
Principal Device Engineer
Dublin
Project Manager - R&D
Galway
Principal Scientist/Engineer Medical Dev
Dublin
Manufacturing Engineer
Cork
R&D Manager
Galway
Quality Engineer
Galway
Lead Manufacturing Technician
Kilkenny
Process Simulation Technical Engineer
Carlow
Senior Tech Transfer Specialist
Meath
Quality Technician
Dublin
Senior R&D Engineer
Galway
Senior Quality Engineer
Leitrim
Product Development Engineer
Dublin
R&D Engineer
Galway
Principal Preclinical Scientist
Galway
Senior R&D Engineer-New Product Deve
Westmeath
Quality Engineer
Galway
R&D Manager
Galway
CAPA Specialist
Cavan
Staff Systems Engineer
Limerick
Project Manager Design Assurance
Galway
Quality Manager
Dublin
Compliance Specialist
Carlow
Technical Life Cycle & Engineering M
Galway
R&D Engineer
Galway
Senior Regulatroy Affairs Specialsit
Galway
Principal Software Engineer
Athlone
R&D Manager
Dublin
R&D Manager
Connaught
Senior Quality Engineer
Leitrim
Project Manager
Kildare
R&D Program Manager
Dublin
R&D Engineer
Galway
R&D Engineer
Clare
Product Development Technician II
Galway
Design Assurance Engineer
Clare
Senior Recruitment Consultant
Republic of Ireland
Senior Technical Transfer Specialist
Cork
Senior R&D Engineer
Galway
Senior Validation Engineer
Louth
Principal Preclinical Scientist
Galway
Lead Maintenance Reliability Engineer
Westmeath
Electronic Engineer
Dublin
Senior Recruitment Consultant
Republic of Ireland
Project/Process Engineer - Purification
Cork
R&D Engineer
Galway
Senior Quality Systems Engineer
Galway
Quality Engineer
Athlone
QC Bioanalytical Analyst
Dublin North
Senior Research and Development Engineer
Galway
Project Engineer
Clare
Quality Control Technician
Carlow
Applications Scientist
Dublin
Senior Quality Systems Engineer
Galway
Warehouse Operator
Meath
Senior Human Factors Engineer
Dublin
R&D Manager
Galway
Senior Project Engineer
Cavan
Senior R&D Engineer
Clare
Field Service Engineer (Chromatography e
Westmeath
Senior R&D Engineer
Galway
Senior R&D Manager/Director
Dublin
QA Engineer
Leitrim
Senior Human Factors Engineer
Dublin
Senior QC Associate
Dublin
Principal R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Senior Electronic Engineer
Dublin
Quality Manager
Galway
R&D Director
Galway
Technical Transfer Specialist
Cork
Senior Design Engineer
Dublin
Senior Design Assurance Engineer
Galway
CTO
Galway
Senior Quality Engineer
Leitrim
Senior Electronic Engineer - Regulated M
Galway
R&D Manager
Connaught
Design Assurance Engineer
Galway
Senior Validation Engineer
Carlow
Quality Engineer
Galway
Senior R&D Engineer
Galway
R&D Engineer
Dublin
Quality Engineer
Galway
Senior R&D Engineer
Galway
Process Chemist
Limerick
R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Dublin
Principal Engineer
Galway
QA Manager
Canada
Senior QA Specialist (hybrid)
Tipperary
Electronic Engineering
Dublin
Senior R&D Engineer
Galway
Principal/Senior R&D Engineer Cathet
Galway
Senior Regulatory Affairs Specialist
Clare
QC Laboratory Technician (shift)
Carlow
Senior QC Microbiology (24/7 Shift)
Dublin
Chief Medical Officer
Dublin
Quality Specialist
Clare
Quality Specialist
Tipperary
Senior R&D Manager
Athlone
Senior Project Engineer
Cavan
Senior Regulatory Affairs Specialist
Athlone
R&D Manager
Athlone
Process Engineer
Galway
R&D Engineer
Galway
Design Assurance Program Manager
Galway
Principal R&D Engineer
Galway
Design Assurance Engineer
Clare
Biomedical Engineer
Dublin
Electronic Engineer
Dublin
Shift Technician (Injection Moulding)
Kildare
Quality Manager - NPI
Dublin
Project Engineer
Cork
R&D Engineer
Galway
R&D Manager
Galway
Senior Associate Quality Control
Dublin
Commisioning and Qualification Engineer
Cork
Principal R&D Engineer
Dublin
Design Quality Engineer
Galway
Project Engineer
Cork
Business Systems Analyst - Dublin
Dublin
Senior Electronics Engineer
Dublin
Validation Engineer
Athlone
Quality Technician
Dublin
R&D Manager
Galway
Senior Electronics Engineer
Limerick
R&D Engineer
Galway
Operational Excellence Specialist
Cork
Quality Assurance Engineer
Longford
R&D Manager
Galway
Product Development Manager
Galway
Head of R&D
Galway
R&D Engineer
Galway
Senior R&D Engineer
Galway
Manufacturing Technician
Clare
Purchasing & Planning Manager
Wexford
Injection Molding Engineer
North Leinster
Manufacturing Project Engineer
Mayo
Regulatory Affairs Maanger
Galway
Product Development Engineer
Dublin
Principal Process Development Engineer
Galway
Biomedical Engineer
Dublin
Quality Engineer
Galway
Technology Transfer Specialist
Meath
Project Engineer
Limerick
Project Manager - R&D
Galway
Senior Validation Engineer
Carlow
Design Assurance Engineer
Galway
Maintenance & Reliability Technician
Limerick
Senior Process Engineer
Dublin
R&D Engineer
Dublin
Mechanical Technician - 2 Cycle
Carlow
Senior Manufacting Engineer
Republic of Ireland
Quality Engineer
Galway
R&D Technician II
Galway
NPI Process Engineer
Carlow
R&D Manager
Galway
Manufacturing Engineer
Cork
Design Assurance Engineer
Galway
Facilities Engineer
Carlow
MS&T Associate Director
Dublin
QC Separation Analyst
Cork
Senior R&D Engineer
Galway
R&D Director
Galway
QC Lab Equipment Specialist
Dublin
Electrical Engineering
Dublin
Senior Quality Engineer
Dublin
Quality Engineer
Galway
Senior R&D Engineer
Galway
R&D Manager
Galway
Senior Operations Engineer
Galway
Senior QC Associate
Dublin
R&D Manager
Galway
Consultant




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

Scientific Writer Regulatory

Scientific Writer Regulatory Our client, a global pharma company, are currently growing their Global Scientific Communications team and are currently seeking a skilled Scientific Writer Regulatory to join their team on a permanent basis. As Scientific Writer Regulatory you will be responsible for the creation of high-quality regulatory documents (e.g., clinical study reports, briefing packages, regulatory responses, IND/MAA submissions). The role involves collaborating with cross-functional teams to ensure clear, accurate, and compliant scientific content throughout ...

Location: Cork,
Scientific Writer Regulatory 		Cork 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

Notified Body Product Assessor -Active Devices

Product Assessor – Active Devices and SaMD Our client a global notified body is currently seeking a Product Assessor for their active and Software as a Medical Device portfolio. Reporting to Technical Business Development Director Business the product assessor will conduct technical documentation reviews against European Medical Device Directive and Medical Device Regulation for Class I/ IIa /IIb and/or Class III within the defined timeframe. This role sits in global group and provides a fantastic career opportunity to shape and develop the role. Su...

Location: Canada, Outside EU,
Notified Body Product Assessor -Active Devices 		Canada 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.