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Quality Manager
Dublin
Dublin
Embedded Software Engineer
Dublin
Dublin
Maintenance CMMS Engineer
Tipperary
Tipperary
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Electronic Engineer
Dublin
Dublin
Senior Quality Engineer-Remote
Republic of Ireland
Republic of Ireland
Production Operator
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Dublin
Senior Design Assurance Engineer
Athlone
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Product Development Engineer II
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Athlone
Manufacturing Technician
Clare
Clare
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
Quality Assurance Engineer
Longford
Longford
R&D Technician
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Galway
Quality Specialist & Deputy RP
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Limerick
R&D Engineer
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Galway
Lead Project Engineer
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Carlow
R&D Manager
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Galway
Reliability Engineer
Tipperary
Tipperary
R&D Senior Program Manager
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Galway
Senior Quality Engineer
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Leitrim
Senior R&D Engineer
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Senior Design Engineer
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Dublin
Senior R&D Engineer
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Quality Engineer
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Galway
R&D Engineer
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Galway
R&D Manager
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Connaught
Injection Moulding Engineer
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Athlone
Manufacturing Engineer
Galway
Galway
EHS Specialist
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Meath
Head of R&D
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Galway
Product Development Engineer
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Galway
Senior Design Engineer
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Medical Writer
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Cork
QC Systems Specialist
Dublin
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QC Laboratory Technician
Carlow
Carlow
Production Operator
Meath
Meath
R&D Engineer
Galway
Galway
Senior Validation Engineer
Carlow
Carlow
Senior R&D Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
Product Development Engineer
Dublin
Dublin
Principal Device Engineer
Dublin
Dublin
Principal Quality Engineer
Galway
Galway
Senior Operations Engineer
Galway
Galway
R&D Project Manager
Galway
Galway
Principal Engineer - R&D
Galway
Galway
Senior Engineering Manager
Limerick
Limerick
Biostatistician
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Dublin City Centre
Electronic Design Engineer
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Galway
Project Manager - R&D
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Galway
Quality Specialist
Tipperary
Tipperary
EHS Systems Specialist
Dublin
Dublin
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
VP of Operations
Dublin
Dublin
QA Validation Specialist
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Injection Molding Engineer
North Leinster
North Leinster
Principal Equipment Engineer
Dublin
Dublin
Electronic Engineer
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Dublin
Maintenance Reliability Engineer
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Tipperary
Utilities Engineer
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Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
Product Development Engineer
Dublin
Dublin
R&D Formulation Chemist
Dublin
Dublin
Senior Analytical Specialist
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Limerick
Investigation Lead
Dublin
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Engineering Shift Technician
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Project Engineer
Clare
Clare
Senior Microbiologist
Dublin
Dublin
Production Operator
Carlow
Carlow
Applications Scientist
Dublin
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Engineering Projects Lead
Carlow
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Operations Engineer
Galway
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Strategic Automation Lead
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Waterford
Quality Manager
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Scientist (hybrid)
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Account Manager UK and Ireland
Republic of Ireland
Republic of Ireland
Injection Moulding Engineer
Athlone
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R&D Director
Galway
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R&D Director
Galway
Galway
Injection Moulding Engineer
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Senior QC Associate
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Technical Transfer Specialist - Remote
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Quality Engineer
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Senior Electronic Engineer
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Manufacturing Technician
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Chief Medical Officer
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Quality Manager
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Senior Electronic Engineer
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Senior R&D Engineer
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Associate R&D Engineer
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CTO
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Maintenance Technician
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Quality Engineer
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Principal Equipment Engineer
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MS&T Associate Director
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Quality Systems Specialist
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Operations Manager
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Senior R&D Engineer
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E&I Turnover Engineer
Carlow
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Senior Design Engineer
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Project Manager - R&D
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Project Manager - R&D
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Quality Technician
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R&D Engineer
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Clean Utilities Engineer
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Quality Engineer
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R&D Engineer
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Quality Control NPI Senior Associate
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Project Engineer
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Electronic Engineer
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Senior R&D Manager/Director
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R&D Engineer
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R&D Manager
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Associate R&D Engineer
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Project Manager - R&D
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Project Manager
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Manufacturing Engineer
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Quality Specialist
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R&D Manager
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QA/ Compliance Officer
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Product Development Engineer
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Operations Engineer
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Senior Regulatory Affairs Specialist
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Quality Control Technician
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Senior Project Engineer
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Principal Process Equipment Engineer
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Program Manager
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Production Operator
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MS&T Bioprocess Engineer
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Project Engineer
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Senior R&D Manager
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Principal Equipment Engineer
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Senior R&D Engineer
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Product Development Engineer II
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Senior QC Microbiology
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Product Development Engineer
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Responsible Person (RP)
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Senior Quality Engineer
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R&D Engineer
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Senior R&D Manager
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Director of Quality Engineering
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SAP Analyst - Logistics & Supply Cha
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Injection Molding Engineer
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Operations Manager
Galway
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Principal R&D Engineer
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Injection Moulding Engineer
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Senior R&D Engineer
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Sourcing Specialist
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Principal Equipment Engineer
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Senior Quality Engineer
Leitrim
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Quality Engineer
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Principal Equipment Engineer
Dublin
Dublin
Principal Equipment Engineer
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Senior Mechanical Engineer
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Dublin
R&D Engineer
Galway
Galway
Quality Engineer
Galway
Galway
Process Engineer
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Senior Operations Engineer
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Quality Control Technician
Carlow
Carlow
Quality Specialist
Clare
Clare
Maintenance Technician
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Manufacturing Engineer
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Process Development Engineer
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Senior R&D Engineer
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Senior Equipment Engineer
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Change Control SME
Cork
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Production Operator
Dublin
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Electronic Engineer
Dublin
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Compliance Specialist
Carlow
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Senior R&D Engineer
Galway
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Lead Maintenance Reliability Engineer
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R&D Technician II
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Galway
Quality Engineer
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Galway
Senior R&D Engineer
Galway
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Senior R&D Engineer
Dublin
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Quality Systems Specialist
Tipperary
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Maintenance Technician
Carlow
Carlow
Project Engineer
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Cork
Operations Engineer
Galway
Galway
Senior Operations Engineer
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Galway
Principal Equipment Engineer
Dublin
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Senior Electrical Engineer
Galway
Galway
R&D Engineer
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Galway
Quality Operations Manager
Dublin
Dublin
Production Operator
Meath
Meath
Principal R&D Engineer
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Dublin
QA Engineer
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Senior QC 24/7 Shift
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Dublin
Production Operator
Carlow
Carlow
Principal Equipment Engineer
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Dublin
QA Manager
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Canada
Senior Regulatory Affairs
Galway
Galway
R&D Program Manager
Dublin
Dublin
Operations Engineer
Galway
Galway
Project Manager - R&D
Galway
Galway
Principal Engineer
Dublin
Dublin
Production Operator
Carlow
Carlow
Process Support Specialist
Carlow
Carlow
R&D Manager
Athlone
Athlone
Principal R&D Engineer
Galway
Galway
Quality Control Technician
Carlow
Carlow
Associate R&D Engineer
Galway
Galway
Senior Associate QC
Dublin
Dublin
Quality Director
Galway
Galway
R&D Manager
Galway
Galway
Senior R&D Engineer
Galway
Galway
R&D Manager
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Athlone
Biomedical Engineer
Dublin
Dublin
Associate R&D Engineer
Galway
Galway
Quality Engineer
Galway
Galway
Principal Equipment Engineer
Dublin
Dublin
R&D Engineer
Galway
Galway
Quality Technician
Dublin
Dublin
Quality Engineer
Athlone
Athlone
Senior Quality Engineer
Leitrim
Leitrim
Utilities Engineer - Black Utilities
Roscommon
Roscommon
Manufacturing Technician
Clare
Clare
Principal Engineer - R&D
Galway
Galway
Principal Engineer - R&D
Galway
Galway
R&D Engineer
Galway
Galway
Product Development Manager
Galway
Galway
Quality Engineer
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Facilities Engineer
Carlow
Carlow
Product Development Engineer II
Athlone
Athlone
Senior QA Associate (Shift)
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Dublin
Mechanical Design Engineer
Germany
Germany
Injection Molding Engineer
North Leinster
North Leinster
Senior Maintenance Technician
Roscommon
Roscommon
Quality Engineer
Galway
Galway
Project Engineer
Limerick
Limerick
Electronic Engineer
Dublin
Dublin
R&D Manager
Connaught
Connaught
Product Development Engineer
Dublin
Dublin
Senior Electronics Engineer
Dublin
Dublin
NPI Process Engineer
Carlow
Carlow
R&D Manager
Galway
Galway
R&D Engineer
Galway
Galway
R&D Engineer
Galway
Galway
Senior Quality Engineer
Galway
Galway
Quality Engineer
Galway
Galway
Maintenance Technician
Kilkenny
Kilkenny
Process Safety Specialist
Tipperary
Tipperary
Process Chemist
Limerick
Limerick
R&D Engineer
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Graduate Manufacturing Technician
Kilkenny
Kilkenny
Reliability Engineering Consultant - Rem
Republic of Ireland
Republic of Ireland
Manufacturing Technician
Clare
Clare
Principal Software Engineer
Athlone
Athlone
Senior Manager Bioanalytical QC Lab
Limerick
Limerick
Product Development Engineer
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Quality Manager - Medical Devices
Limerick City
Limerick City
Senior Electronic Engineer
Dublin
Dublin
QA Manager
Canada
Canada
Technical Administrator
Tipperary
Tipperary
Principal Engineer
Dublin
Dublin
Validation Engineer
Athlone
Athlone
Quality Engineer
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Senior Quality Engineer
Galway
Galway
R&D Manager
Dublin
Dublin
Quality Technician
Dublin
Dublin
Manufacturing Engineer
Wexford
Wexford
Electronic Engineering
Dublin
Dublin
MS&T Associate Director
Dublin
Dublin
Senior Process Engineer
Dublin
Dublin
Microbiology Manager
Dublin
Dublin
R&D Technician II
Galway
Galway
Senior Quality Control Associate
Dublin South
Dublin South
NPI Process Engineer
Carlow
Carlow
Quality Engineer
Athlone
Athlone
Senior R&D Engineer
Galway
Galway
Quality Systems Manager
Dublin
Dublin
Production Operator
Meath
Meath
R&D Director
Galway
Galway
R&D Manager
Connaught
Connaught
Senior Validation Engineer
Dublin
Dublin
EHS Officer
Dublin
Dublin
R&D Lifecycle Manager
Connaught
Connaught
R&D Engineer
Galway
Galway
Principal R&D Engineer
Galway
Galway
Senior Quality Engineer
Leitrim
Leitrim
Product Development Manager
Galway
Galway
Quality Engineer
Galway
Galway
Electronic Engineer
Dublin
Dublin
Biomedical Engineer
Dublin
Dublin
R&D Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
R&D Director
Galway
Galway
Product Development Engineer
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Material Handler
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Search Results for Regulatory Affairs Specialist
Job Title. | Location | Salary | Actions |
Associate Director - Global Core Labeling (Regulatory Affairs)Associate Director - Global Core Labeling (Regulatory Affairs) Our client is a global healthcare leader with employees around the world who work to discover and bring life-changing medicines to those who need them. They are seeking a Global Labelling Lead who shall be at Associate Director level to join a growing team of Regulatory professionals within their Global Business Centre.The purpose of the Associate Director, Global Regulatory Affairs (GRA) Global Core Labeling role is to lead the development and maintenance of global labeling, including all core labelin...Location: Cork, |
Cork | Not Disclosed | |
Senior Regulatory Affairs SpecialistJob 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, |
EU | Not Disclosed | |
Senior Regulatory Affairs SpecialistJob 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, |
EU | Not Disclosed | |
Senior Regulatory Affairs SpecialistJob 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, |
EU | Not Disclosed | |
Senior Regulatory Affairs SpecialistJob 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, |
EU | Not Disclosed | |
Senior Regulatory Affairs SpecialistJob 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, |
EU | Not Disclosed | |
Senior Reg Affairs Specialist - Post MarketJob 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, |
Galway | Not Disclosed | |
Senior Regulatory Affairs SpecialistJob 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, |
EU | Not Disclosed | |
Regulatory Affairs SpecialistRegulatory 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, |
Cork | Not Disclosed | |
Senior Regulatory Affairs SpecialistSenior Regulatory Affairs Specialist Our client a Medical Device Multinational currently seeks a Senior Regulatory Specialist to join their team. The Senior. Regulatory Affairs Specialist will develop strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction. The Sr. Regulatory position will assist in mentoring and development of staff members as part of the role. Role/Responsibilities • Manage Technical Documentation ...Location: Westmeath, |
Westmeath | Not Disclosed |
Regulatory Affairs Specialist Career Profile
Regulatory Affairs Specialist
There are Regulatory Affairs (RA) opportunities available in a variety of industries: Pharmaceutical / Biotech / Agrochemical / Clinical Research Organisations (CRO's). There also exist roles in Consultancy organisations, companies which service small and large Clients in the above industries, on various projects. These can often be interesting and varied roles for the experienced RA professional.Salary Scale:
- Regulatory Affairs Assistant - €25,000 - €28,000
- Regulatory Affairs Officer - €32,000 - €39,000
- Regulatory Affairs Specialist - €40,000 - €55,000
- Regulatory Affairs Manager - €60,000 - €80,000
- Regulatory Affairs Director - €85,000 +
Role 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 pharmaceutical 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.
Industry 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.
Biotechnology Mayo Scientist Pharmaceutical Product Development Engineer Sales and Marketing Academic Quality Engineering PhD Cork City Microbiology Dublin Pharma Sales Supply Chain Scientific Validation Engineer Cork Diagnostics Manufacturing Executive Medical Affairs Allied Healthcare Academic Engineering Supply Chain Quality Assurance Chemistry Clinical Research Connected Health Limerick Quality Control Packaging Engineer Project Manager IT Laboratory Scientist Sales and Marketing Biopharmaceutical Life Science Medical Device
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
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