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Quality Director
Galway
Galway
Injection Molding Engineer
North Leinster
North Leinster
R&D Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
Electronic Engineer
Dublin
Dublin
Process Engineer
Cork
Cork
Product Development Engineer II
Athlone
Athlone
Principal Engineer
Dublin
Dublin
Production Operator
Meath
Meath
Quality Technician
Dublin
Dublin
SAP Analyst - Logistics & Supply Cha
Limerick
Limerick
R&D Technician II
Galway
Galway
Manufacturing Engineer
Galway
Galway
Quality Engineer
Athlone
Athlone
Lead Project Engineer
Carlow
Carlow
Senior R&D Engineer
Dublin
Dublin
Process Development Engineer
Galway
Galway
Quality Manager
Galway
Galway
Production Operator
Dublin
Dublin
Project Manager - R&D
Galway
Galway
Product Development Engineer II
Athlone
Athlone
Senior Quality Engineer
Dublin
Dublin
Process Chemist
Limerick
Limerick
Principal Data Architect
Limerick
Limerick
Electronic Engineer
Dublin
Dublin
Project Manager - R&D
Galway
Galway
Quality Systems Specialist
Tipperary
Tipperary
Chief Medical Officer
Dublin
Dublin
Applications Scientist
Dublin
Dublin
Senior QC Associate
Dublin
Dublin
Senior Project Engineer
Cavan
Cavan
Sourcing Specialist
Tipperary
Tipperary
R&D Engineer
Dublin
Dublin
Quality Engineer
Galway
Galway
Quality Engineer
Galway
Galway
R&D Director
Galway
Galway
Senior Quality Engineer
Galway
Galway
R&D Engineer
Galway
Galway
Project Engineer
Roscommon
Roscommon
Project Engineer
Cork
Cork
Quality Engineer
Galway
Galway
R&D Director
Galway
Galway
R&D Engineer
Galway
Galway
Product Development Engineer
Dublin
Dublin
R&D Engineer
Galway
Galway
Production Operator
Carlow
Carlow
R&D Engineer
Dublin
Dublin
Injection Moulding Engineer
Leitrim
Leitrim
Production Operator
Dublin
Dublin
MS&T Associate Director
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Account Manager UK and Ireland
Republic of Ireland
Republic of Ireland
Product Development Engineer
Galway
Galway
Senior Process Engineer
Dublin
Dublin
R&D Engineer
Galway
Galway
Injection Moulding Engineer
Athlone
Athlone
Quality Manager
Dublin
Dublin
Biostatistician
Dublin City Centre
Dublin City Centre
Electronic Engineer
Dublin
Dublin
Principal Engineer - R&D
Galway
Galway
Senior Design Engineer
Dublin
Dublin
Manufacturing Technician
Clare
Clare
QC Laboratory Technician
Carlow
Carlow
Project Engineer
Clare
Clare
Graduate Manufacturing Technician
Kilkenny
Kilkenny
R&D Engineer
Galway
Galway
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Senior Regulatory Affairs
Galway
Galway
Program Manager
Dublin
Dublin
Responsible Person (RP)
Republic of Ireland
Republic of Ireland
R&D Engineer
Galway
Galway
Quality Specialist
Clare
Clare
Process Support Specialist
Carlow
Carlow
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Senior Quality Control Associate
Dublin South
Dublin South
Principal Process Equipment Engineer
Dublin South
Dublin South
Strategic Automation Lead
Waterford
Waterford
Senior R&D Engineer
Galway
Galway
Senior Electronic Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Engineering Shift Technician
Dublin
Dublin
Senior R&D Manager
Athlone
Athlone
Product Development Manager
Galway
Galway
Quality Specialist
Clare
Clare
Senior QC 24/7 Shift
Dublin
Dublin
Reliability Engineer
Tipperary
Tipperary
Principal Engineer
Dublin
Dublin
Quality Assurance Engineer
Longford
Longford
Principal Quality Engineer
Galway
Galway
Product Development Manager
Galway
Galway
Production Operator
Meath
Meath
Utilities Engineer - Black Utilities
Roscommon
Roscommon
EHS Systems Specialist
Dublin
Dublin
Facilities Engineer
Carlow
Carlow
Senior R&D Engineer
Dublin
Dublin
R&D Engineer
Clare
Clare
Senior R&D Manager
Athlone
Athlone
Manufacturing Engineer
Wexford
Wexford
Production Operator
Carlow
Carlow
Microbiologist
Cork
Cork
Quality Systems Specialist
Tipperary
Tipperary
Senior R&D Manager/Director
Dublin
Dublin
Change Control SME
Cork
Cork
Quality Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
Quality Control NPI Senior Associate
Dublin South
Dublin South
Process Safety Specialist
Tipperary
Tipperary
R&D Manager
Athlone
Athlone
NPI Process Engineer
Carlow
Carlow
Quality Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
Project Manager
Galway
Galway
Microbiology Manager
Dublin
Dublin
Senior Equipment Engineer
Dublin
Dublin
Product Development Engineer
Dublin
Dublin
Quality Manager - NPI
Dublin
Dublin
Senior Engineering Manager
Limerick
Limerick
Injection Molding Engineer
North Leinster
North Leinster
E&I Turnover Engineer
Carlow
Carlow
Product Development Engineer
Dublin
Dublin
Manufacturing Technician
Clare
Clare
Quality Systems Manager
Dublin
Dublin
Senior Electronic Engineer
Dublin
Dublin
CTO
Dublin
Dublin
R&D Director
Galway
Galway
R&D Lifecycle Manager
Connaught
Connaught
Principal R&D Engineer
Dublin
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
R&D Manager
Galway
Galway
R&D Manager
Connaught
Connaught
Project Engineer
Limerick
Limerick
Product Development Engineer
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
R&D Manager
Athlone
Athlone
R&D Manager
Connaught
Connaught
Quality Specialist & Deputy RP
Limerick
Limerick
Injection Molding Engineer
North Leinster
North Leinster
Senior R&D Engineer
Dublin
Dublin
EHS Specialist
Meath
Meath
Senior Electronics Engineer
Limerick
Limerick
Quality Engineer
Athlone
Athlone
Quality Engineer
Galway
Galway
R&D Engineer
Galway
Galway
Embedded Software Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Engineering Business Manager
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Electronic Engineer
Dublin
Dublin
Senior Operations Engineer
Galway
Galway
Engineering Projects Lead
Carlow
Carlow
Senior Electronics Engineer
Dublin
Dublin
Product Development Engineer
Dublin
Dublin
Senior R&D Engineer
Clare
Clare
QA Validation Specialist
Meath
Meath
Senior Quality Engineer
Leitrim
Leitrim
Senior Quality Engineer
Leitrim
Leitrim
Head of R&D
Galway
Galway
Quality Control Technician
Carlow
Carlow
Production Operator
Meath
Meath
Senior R&D Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Senior Manager Bioanalytical QC Lab
Limerick
Limerick
Senior Electronic Engineer
Dublin
Dublin
Quality Manager
Galway
Galway
Senior R&D Engineer
Galway
Galway
DeltaV Lead Automation Engineer
Tipperary
Tipperary
Production Operator
Meath
Meath
Biomedical Engineer
Dublin
Dublin
R&D Manager
Dublin
Dublin
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
Manufacturing Technician
Clare
Clare
Electronic Engineering
Dublin
Dublin
Quality Manager
Wexford
Wexford
Senior Operations Engineer
Galway
Galway
Quality Technician
Dublin
Dublin
Senior Design Engineer
Dublin
Dublin
Project Manager - R&D
Galway
Galway
R&D Manager
Galway
Galway
Senior R&D Engineer
Galway
Galway
Quality Engineer
Galway
Galway
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
EHS Officer
Dublin
Dublin
MS&T Bioprocess Engineer
Meath
Meath
R&D Engineer
Galway
Galway
Material Handler
Carlow
Carlow
Maintenance Reliability Engineer
Tipperary
Tipperary
Quality Specialist
Clare
Clare
Senior Mechanical Engineer
Dublin
Dublin
Senior Quality Engineer-Remote
Republic of Ireland
Republic of Ireland
Biomedical Engineer
Dublin
Dublin
QC Bioanalytical Analyst
Dublin North
Dublin North
Project Engineer
Cork
Cork
Electronic Engineer
Dublin
Dublin
Product Development Engineer
Dublin
Dublin
R&D Program Manager
Dublin
Dublin
Senior Quality Engineer
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Project Manager - R&D
Galway
Galway
Electronic Engineer
Dublin
Dublin
Principal Device Engineer
Dublin
Dublin
Principal R&D Engineer
Dublin
Dublin
Validation Engineer
Athlone
Athlone
R&D Technician II
Galway
Galway
Senior Design Engineer
Dublin
Dublin
Technical Administrator
Tipperary
Tipperary
R&D Project Manager
Galway
Galway
R&D Manager
Connaught
Connaught
Electronic Engineer
Dublin
Dublin
Senior Associate QC
Dublin
Dublin
Principal Software Engineer
Athlone
Athlone
Senior Project Engineer
Cavan
Cavan
R&D Formulation Chemist
Dublin
Dublin
Senior Validation Engineer
Carlow
Carlow
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Project Manager - R&D
Galway
Galway
Senior Maintenance Technician
Roscommon
Roscommon
Quality Engineer
Galway
Galway
Senior Electrical Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
Quality Systems Specialist
Tipperary
Tipperary
Senior R&D Project Manager
Galway
Galway
Senior Analytical Specialist
Limerick
Limerick
Maintenance Technician
Kilkenny
Kilkenny
Quality Engineer
Galway
Galway
Injection Moulding Engineer
Athlone
Athlone
Manufacturing Technician
Clare
Clare
QA Manager
Canada
Canada
Compliance Specialist
Carlow
Carlow
Principal Engineer - R&D
Galway
Galway
Quality Manager - Medical Devices
Limerick City
Limerick City
Quality Control Technician
Carlow
Carlow
Principal Engineer - R&D
Galway
Galway
CTO
Galway
Galway
Electronic Design Engineer
Galway
Galway
Investigation Lead
Dublin
Dublin
Quality Operations Manager
Dublin
Dublin
Senior Microbiologist
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Product Development Engineer II
Athlone
Athlone
QA Manager
Canada
Canada
Reliability Engineering Consultant - Rem
Republic of Ireland
Republic of Ireland
R&D Engineer
Galway
Galway
Senior R&D Engineer
Clare
Clare
VP of Operations
Dublin
Dublin
Senior Validation Engineer
Dublin
Dublin
Senior Design Assurance Engineer
Athlone
Athlone
Principal Engineer
Dublin
Dublin
Quality Engineer
Galway
Galway
Principal R&D Engineer
Galway
Galway
R&D Manager
Galway
Galway
Manufacturing Engineer
Galway
Galway
Quality Technician
Dublin
Dublin
R&D Senior Program Manager
Galway
Galway
Senior Quality Engineer
Leitrim
Leitrim
R&D Manager
Galway
Galway
Senior QA Associate (Shift)
Dublin
Dublin
QA Engineer
Leitrim
Leitrim
Quality Control Technician
Carlow
Carlow
Quality Engineer
Athlone
Athlone
Operations Engineer
Galway
Galway
Maintenance CMMS Engineer
Tipperary
Tipperary
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
Scientist (hybrid)
Meath
Meath
R&D Engineer
Galway
Galway
Maintenance Technician
Carlow
Carlow
Senior Quality Engineer
Leitrim
Leitrim
Principal R&D Engineer
Galway
Galway
Medical Writer
Cork
Cork
Manufacturing Technician
Clare
Clare
Director of Quality Engineering
Limerick
Limerick
Product Development Engineer
Galway
Galway
R&D Engineer
Galway
Galway
Process Engineer
Galway
Galway
Production Operator
Carlow
Carlow
R&D Manager
Connaught
Connaught
Product Development Engineer
Dublin
Dublin
Quality Engineer
Galway
Galway
Quality Engineer
Wexford
Wexford
Clean Utilities Engineer
Carlow
Carlow
Senior R&D Engineer
Galway
Galway
R&D Technician
Galway
Galway
Injection Moulding Engineer
Athlone
Athlone
NPI Process Engineer
Carlow
Carlow
R&D Director
Galway
Galway
Utilities Engineer
Dublin
Dublin
Senior QC Microbiology
Dublin
Dublin
R&D Engineer
Galway
Galway
Mechanical Design Engineer
Germany
Germany
Manufacturing Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
QC Systems Specialist
Dublin
Dublin
Principal Engineer - R&D
Galway
Galway
Laboratory Systems Lead
Meath
Meath
Maintenance Technician
Kilkenny
Kilkenny
Senior R&D Engineer
Galway
Galway
Electronic Engineer
Dublin
Dublin
Quality Specialist
Tipperary
Tipperary
Senior Operations Engineer
Galway
Galway
Injection Molding Engineer
North Leinster
North Leinster
MS&T Associate Director
Dublin
Dublin
Maintenance Technician
Carlow
Carlow
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
Search Results for Regulatory Affairs Executive
Job Title. | Location | Salary | Actions |
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.
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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.
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Experience in writing and submitting regulatory documentation.
Diagnostics Supply Chain Mayo Connected Health Project Manager Biotechnology Life Science Biopharmaceutical Clinical Research Microbiology Medical Device Pharma Sales Pharmaceutical Supply Chain Academic Engineering Packaging Engineer Validation Engineer Cork PhD Chemistry Product Development Engineer Quality Assurance Quality Engineering Cork City Manufacturing Executive Quality Control IT Scientific Allied Healthcare Laboratory Scientist Sales and Marketing Scientist Dublin Academic Limerick Medical Affairs Sales and Marketing
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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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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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