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Lead Maintenance Reliability Engineer
Westmeath
Westmeath
QA Manager
Canada
Canada
R&D Engineer
Galway
Galway
Senior Operations Engineer
Galway
Galway
Process Support Specialist
Carlow
Carlow
Quality Manager
Dublin
Dublin
Instrument Specialist
Tipperary
Tipperary
Recruitment Consultant
Wexford
Wexford
Validation Engineer
Athlone
Athlone
QA Manager
Canada
Canada
R&D Director
Galway
Galway
Senior Equipment Engineer
Dublin
Dublin
Maintenance CMMS Engineer
Tipperary
Tipperary
Compliance Engineer
Carlow
Carlow
Responsible Person (RP)
Republic of Ireland
Republic of Ireland
R&D Director
Galway
Galway
Senior Associate QC
Dublin
Dublin
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
Process Engineer
Galway
Galway
Product Development Engineer
Dublin
Dublin
Quality Operations Manager
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Project Engineer
Tipperary
Tipperary
Change Control Coordinator
Carlow
Carlow
Scientist (hybrid)
Meath
Meath
Electronic Engineer
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Product Development Engineer
Dublin
Dublin
Project Manager - R&D
Galway
Galway
Operations Manager
Wexford
Wexford
Senior R&D Engineer
Dublin
Dublin
Head of R&D
Galway
Galway
Project Manager - R&D
Galway
Galway
Senior QC 24/7 Shift
Dublin
Dublin
Manufacturing Technician
Clare
Clare
Validation Engineer
Cork
Cork
Quality Engineer
Galway
Galway
R&D Manager
Connaught
Connaught
Electronic Engineer
Dublin
Dublin
Reliability Engineer
Tipperary
Tipperary
R&D Manager
Connaught
Connaught
Senior R&D Engineer
Dublin
Dublin
Quality Engineer
Athlone
Athlone
Senior Electronic Engineer
Dublin
Dublin
Maintenance CMMS Engineer
Tipperary
Tipperary
Process Engineer
Limerick
Limerick
Master Data Associate
Limerick
Limerick
Quality Engineer
Galway
Galway
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Senior Microbiology Specialist - Greece
Republic of Ireland
Republic of Ireland
NPI Process Engineer
Carlow
Carlow
Production Operator
Carlow
Carlow
Quality Technician
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
Process Development Engineer
Galway
Galway
EHS Systems Specialist
Dublin
Dublin
Senior R&D Manager/Director
Dublin
Dublin
Project Process Engineer
Carlow
Carlow
R&D Director
Galway
Galway
Senior Microbiologist
Republic of Ireland
Republic of Ireland
Technical Transfer Lead
Dublin
Dublin
Project Manager
Limerick
Limerick
Senior R&D Manager
Athlone
Athlone
Injection Molding Engineer
North Leinster
North Leinster
Maintenance Engineer
Carlow
Carlow
Maintenance Engineer
Cork
Cork
Senior Engineering Manager
Limerick
Limerick
NPI Process Engineer
Carlow
Carlow
Lead Project Engineer
Carlow
Carlow
Senior R&D Engineer
Dublin
Dublin
R&D Senior Program Manager
Galway
Galway
Quality Control Technician
Carlow
Carlow
Product Development Engineer II
Athlone
Athlone
QC Laboratory Technician
Carlow
Carlow
Remote Process Engineer - Fill Finish
Republic of Ireland
Republic of Ireland
Manufacturing Engineer
Galway
Galway
Maintenance Technician
Carlow
Carlow
Principal Equipment Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Quality Specialist
Tipperary
Tipperary
Project Manager
Galway
Galway
Injection Moulding Engineer
Athlone
Athlone
Principal Software Engineer
Athlone
Athlone
Production Operator
Dublin
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Quality Specialist
Clare
Clare
Project Manager - R&D
Galway
Galway
Production Operator
Dublin
Dublin
Senior Electronic Engineer
Dublin
Dublin
Engineering Projects Lead
Carlow
Carlow
VP of Operations
Dublin
Dublin
Account Manager UK and Ireland
Republic of Ireland
Republic of Ireland
Electronic Engineer
Dublin
Dublin
Principal R&D Engineer
Dublin
Dublin
Senior Quality Engineer
Limerick
Limerick
Quality Technician
Dublin
Dublin
Principal Device Engineer
Dublin
Dublin
Embedded Software Engineer
Dublin
Dublin
Suite Team Delivery Lead
Tipperary
Tipperary
MS&T Associate Director
Dublin
Dublin
Senior Operations Engineer
Galway
Galway
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Electronic Design Engineer
Galway
Galway
Manufacturing Engineer
Galway
Galway
Process Engineer
Cork
Cork
R&D Engineer
Dublin
Dublin
Senior QC Associate
Dublin
Dublin
R&D Manager
Athlone
Athlone
Manufacturing Engineer
Limerick
Limerick
Senior Project Engineer
Cavan
Cavan
EHS Specialist
Carlow
Carlow
Chief Medical Officer
Dublin
Dublin
Quality Technician
Dublin
Dublin
Manufacturing Engineer
Wexford
Wexford
R&D Manager
Dublin
Dublin
Project Enginer
Dublin South
Dublin South
Facilities Engineer
Carlow
Carlow
R&D Engineer
Galway
Galway
Program Manager
Dublin
Dublin
E&I Turnover Engineer
Carlow
Carlow
R&D Engineer
Clare
Clare
Specialist Operations Engineer
Tipperary
Tipperary
R&D Technician II
Galway
Galway
Quality Engineer
Galway
Galway
Senior Mechanical Engineer
Dublin
Dublin
MS&T Associate Director
Dublin
Dublin
Product Development Engineer
Dublin
Dublin
Project Manager - R&D
Galway
Galway
Senior Process Engineer
Dublin
Dublin
Injection Molding Engineer
North Leinster
North Leinster
Production Operator
Meath
Meath
Product Development Engineer
Dublin
Dublin
Product Development Engineer
Galway
Galway
Production Operator
Carlow
Carlow
Injection Molding Engineer
North Leinster
North Leinster
Project Engineer
Republic of Ireland
Republic of Ireland
Manufacturing Technician
Clare
Clare
Principal R&D Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Product Development Engineer
Galway
Galway
Senior R&D Manager
Athlone
Athlone
Senior Validation Engineer
Limerick
Limerick
Program Manager
Cork
Cork
Utilities Engineer - Black Utilities
Roscommon
Roscommon
Electrical Engineer
Limerick
Limerick
SAP Analyst - Logistics & Supply Cha
Limerick
Limerick
Senior Design Engineer
Dublin
Dublin
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Principal Process Equipment Engineer
Dublin South
Dublin South
Engineering Business Manager
Dublin
Dublin
Quality Manager - NPI
Dublin
Dublin
Project Engineer
Limerick
Limerick
Senior Quality Engineer
Leitrim
Leitrim
R&D Technician II
Galway
Galway
Senior Validation Engineer
Carlow
Carlow
Senior Operations Engineer
Galway
Galway
Senoior Specialist - MS&T
Dublin
Dublin
Clean Utilities Engineer
Carlow
Carlow
Quality Engineer
Galway
Galway
Microbiology Manager
Dublin
Dublin
Manufacturing Technician
Clare
Clare
Principal R&D Engineer
Galway
Galway
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
R&D Manager
Galway
Galway
Senior Quality Engineer
Galway
Galway
Quality Control NPI Senior Associate
Dublin South
Dublin South
Project Manager - Suite Lead
Tipperary
Tipperary
R&D Engineer
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Senior Electronics Engineer
Dublin
Dublin
R&D Engineer
Dublin
Dublin
Recruitment Consultant
Republic of Ireland
Republic of Ireland
Senior Validation Engineer
Dublin
Dublin
Manufacturing Engineer
Galway
Galway
Manufacturing Technician
Clare
Clare
R&D Lifecycle Manager
Connaught
Connaught
Senior Electronic Engineer
Dublin
Dublin
Injection Molding Engineer
North Leinster
North Leinster
Senior Supply Chain Manager
Wexford
Wexford
Product Lead
Dublin
Dublin
Senior R&D Project Manager
Galway
Galway
Principal Engineer
Dublin
Dublin
CQV Lead
Tipperary
Tipperary
Senior Maintenance Technician
Roscommon
Roscommon
Clean Utilities Engineer
Carlow
Carlow
Product Development Engineer
Galway
Galway
Principal Instrumentation Engineer
Limerick
Limerick
Quality Systems Manager
Dublin
Dublin
Quality Specialist
Clare
Clare
Senior R&D Engineer
Clare
Clare
Product Development Manager
Galway
Galway
Quality Systems Specialist
Galway
Galway
Strategic Automation Lead
Waterford
Waterford
Process Engineer (NPI)
Carlow
Carlow
R&D Engineer
Galway
Galway
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
Engineering Shift Technician
Dublin
Dublin
Production Operator
Carlow
Carlow
Quality Engineer
Wexford
Wexford
Biostatistician
Dublin City Centre
Dublin City Centre
Senior Associate Buyer
Dublin
Dublin
Principal R&D Engineer
Galway
Galway
Technical Sales Manager (Chemistry)
Westmeath
Westmeath
Senior R&D Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
Director of Quality Engineering
Limerick
Limerick
Senior Project Engineer
Cavan
Cavan
R&D Technician
Galway
Galway
Maintenance Planner
Westmeath
Westmeath
Quality Assurance Engineer
Longford
Longford
Injection Moulding Engineer
Athlone
Athlone
Facilities Engineer
Carlow
Carlow
R&D Director
Galway
Galway
Quality Engineer
Athlone
Athlone
Senior R&D Engineer
Galway
Galway
Production Operator
Meath
Meath
Injection Moulding Engineer
Athlone
Athlone
Clinical Monitor
Dublin
Dublin
R&D Project Manager
Galway
Galway
Quality Engineer
Galway
Galway
Chemical Engineer
Tipperary
Tipperary
Investigation Lead
Dublin
Dublin
Product Development Engineer II
Athlone
Athlone
Senior Quality Engineer
Leitrim
Leitrim
Senior Design Engineer
Dublin
Dublin
Maintenance Reliability Engineer
Tipperary
Tipperary
R&D Manager
Connaught
Connaught
Senior Validation Engineer
Dublin
Dublin
Mechanical Design Engineer
Germany
Germany
Senior Quality Engineer
Leitrim
Leitrim
Senior R&D Engineer
Dublin
Dublin
Warehouse Manager
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Quality Engineer
Galway
Galway
Technical Administrator
Tipperary
Tipperary
Senior Validation Engineer
Dublin
Dublin
Quality Manager
Galway
Galway
Senior HVAC Engineer
Dublin
Dublin
Senior Quality Engineer
Galway
Galway
Product Development Engineer II
Athlone
Athlone
Compliance Specialist
Carlow
Carlow
Senior R&D Engineer
Galway
Galway
MS&T Bioprocess Engineer
Meath
Meath
Product Development Engineer
Dublin
Dublin
R&D Manager
Connaught
Connaught
R&D Manager
Galway
Galway
Senior Validation Engineer
Limerick
Limerick
Project Engineer
Roscommon
Roscommon
R&D Engineer
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Quality Validation Engineer
Limerick
Limerick
QC Instrumentation Engineer
Limerick
Limerick
Product Development Manager
Galway
Galway
R&D Program Manager
Dublin
Dublin
QA Engineer
Leitrim
Leitrim
Project Engineer
Clare
Clare
Technical Services Manager
Tipperary
Tipperary
Senior Regulatory Affairs
Galway
Galway
Operations Specialist
Louth
Louth
Aseptic Process Lead
Carlow
Carlow
C&Q Lead
Tipperary
Tipperary
Process Support Specialist
Carlow
Carlow
R&D Project Manager
Galway
Galway
Buyer
Wexford
Wexford
Material Handler
Carlow
Carlow
Senior Electrical Engineer
Galway
Galway
Quality Specialist
Tipperary
Tipperary
Injection Moulding Engineer
Leitrim
Leitrim
Medical Writer
Cork
Cork
Senior Quality Engineer-Remote
Republic of Ireland
Republic of Ireland
Senior Quality Engineer
Leitrim
Leitrim
Sourcing Specialist
Tipperary
Tipperary
R&D Engineer
Galway
Galway
Manufacturing Technician
Clare
Clare
Packaging Engineer
Dublin
Dublin
Senior Quality Control Associate
Dublin South
Dublin South
Quality Engineer
Athlone
Athlone
R&D Engineer
Galway
Galway
R&D Manager
Galway
Galway
Principal Quality Engineer
Galway
Galway
Validation Engineer
Limerick
Limerick
Business Manager (Pharma Chemicals)
Westmeath
Westmeath
Principal Engineer
Dublin
Dublin
Quality Engineer
Galway
Galway
Senior Microbiologist
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Principal Engineer
Dublin
Dublin
Process Chemist
Limerick
Limerick
R&D Manager
Galway
Galway
Senior Design Engineer
Dublin
Dublin
Senior Validation Engineer
Dublin
Dublin
R&D Engineer
Galway
Galway
Quality Specialist
Dublin
Dublin
QA Compliance Specialist
Carlow
Carlow
Senior R&D Engineer
Clare
Clare
Process Engineer (Shift)
Carlow
Carlow
Biomedical Engineer
Dublin
Dublin
Maintenance Reliability Engineer
Tipperary
Tipperary
Project Manager - R&D
Galway
Galway
Quality Control Technician
Carlow
Carlow
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Validation Engineer
Carlow
Carlow
Biomedical Engineer
Dublin
Dublin
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
Quality Specialist
Clare
Clare
Change Control SME
Cork
Cork
R&D Engineer
Galway
Galway
Quality Control Technician
Carlow
Carlow
Global Safety Senior Manager
Dublin
Dublin
Maintenance Engineer
Cork
Cork
Applications Scientist
Dublin
Dublin
Electrical Engineer
Cork
Cork
Senior Quality Engineer
Dublin
Dublin
Senior QC Associate
Dublin
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
Manufacturing Engineer
Galway
Galway
R&D Manager
Athlone
Athlone
E&I Turnover Engineer
Carlow
Carlow
Search Results for Regulatory Affairs Executive
Job Title. | Location | Salary | Actions |
Principal Scientist Global Regulatory Affairs CMCPrincipal Scientist- Global Regulatory Affairs-CMC Our client, a global pharma company, are currently recruting for a Principal Scientist- Global Regulatory Affairs-CMC for their Cork based manufacturing site. This is a permanent role withhybrid working. As Principal Scientist- Global Regulatory Affairs-CMC you will provide strategic, tactical and operational direction to expedite the CMC development of the organisations portfolio and technical agenda by supporting global clinical trial, market registration submissions, and post-approval submissions. Resp...Location: Cork, |
Cork | Not Disclosed | |
Notified Body Product Assessor -Active DevicesProduct 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, |
Canada | 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 |
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.
Sales and Marketing Cork Allied Healthcare Medical Device Pharma Sales Biotechnology Academic Life Science Microbiology Packaging Engineer Biopharmaceutical Pharmaceutical Manufacturing Executive Connected Health IT Supply Chain Quality Control Academic Chemistry Sales and Marketing Scientific Cork City Medical Affairs Scientist Limerick Validation Engineer Project Manager Dublin Supply Chain Engineering PhD Quality Engineering Diagnostics Clinical Research Laboratory Scientist Product Development Engineer Mayo Quality Assurance
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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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