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Project Engineer
Cork
Cork
Senior Electrical Engineer
Galway
Galway
Regulatory Associate
Cork
Cork
Senior Electronic Engineer
Dublin
Dublin
Senior Manager Bioanalytical QC Lab
Limerick
Limerick
Principal Engineer - R&D
Galway
Galway
Reg Affairs Specialist
Connaught
Connaught
Senior R&D Engineer
Galway
Galway
Process Chemist
Limerick
Limerick
Reg Affairs Specialist
Connaught
Connaught
Quality Engineer
Galway
Galway
Senior Quality Engineer
Leitrim
Leitrim
Injection Molding Engineer
North Leinster
North Leinster
QA Engineer
Leitrim
Leitrim
Quality Technician
Dublin
Dublin
Product Development Engineer
Dublin
Dublin
Production Operator
Meath
Meath
Manufacturing Technician
Clare
Clare
Project Manager - R&D
Galway
Galway
Change Control Lead
Tipperary
Tipperary
Injection Moulding Engineer
Leitrim
Leitrim
Sourcing Specialist
Tipperary
Tipperary
E&I Turnover Engineer
Carlow
Carlow
Senior Quality Engineer
Galway
Galway
DeltaV Lead Automation Engineer
Tipperary
Tipperary
R&D Manager
Connaught
Connaught
Project Manager
Louth
Louth
Scientist (hybrid)
Meath
Meath
R&D Manager
Athlone
Athlone
Senior Design Engineer
Dublin
Dublin
Injection Moulding Engineer
Athlone
Athlone
Quality Engineer
Galway
Galway
Principal Engineer
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Dublin
Electronic Engineer
Dublin
Dublin
Quality Manager
Dublin
Dublin
Quality Manager - Medical Devices
Limerick City
Limerick City
Senior R&D Engineer
Galway
Galway
Product Development Engineer
Dublin
Dublin
Technical Administrator
Tipperary
Tipperary
Clean Utilities Engineer
Carlow
Carlow
Quality Specialist
Clare
Clare
R&D Lifecycle Manager
Connaught
Connaught
Director of Quality Engineering
Limerick
Limerick
Biomedical Engineer
Dublin
Dublin
Facilities Engineer
Carlow
Carlow
Engineering Business Manager
Dublin
Dublin
Senior Validation Engineer
Carlow
Carlow
Senior Validation Engineer
Carlow
Carlow
Embedded Software Engineer
Dublin
Dublin
Quality Systems Specialist
Tipperary
Tipperary
Quality Technician
Dublin
Dublin
Project Engineer
Roscommon
Roscommon
R&D Engineer
Galway
Galway
Principal Engineer - R&D
Galway
Galway
QC Systems Specialist
Dublin
Dublin
R&D Manager
Galway
Galway
Principal Software Engineer
Athlone
Athlone
Process Engineer
Cork
Cork
Senior R&D Engineer
Galway
Galway
Senior Electronic Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Electronic Engineer
Dublin
Dublin
EHS Officer
Dublin
Dublin
Quality Manager
Galway
Galway
R&D Technician II
Galway
Galway
Principal R&D Engineer
Galway
Galway
Senior Electronics Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Senior Project Engineer
Cavan
Cavan
Product Development Manager
Galway
Galway
Electronic Engineer
Dublin
Dublin
Operations Engineer
Galway
Galway
Biostatistician
Dublin City Centre
Dublin City Centre
Senior Procurement Associate
Limerick
Limerick
Senior Validation Engineer
Dublin
Dublin
Project Engineer
Limerick
Limerick
Investigation Lead
Dublin
Dublin
Project Engineer
Clare
Clare
Senior R&D Engineer
Clare
Clare
Quality Engineer
Galway
Galway
Product Development Engineer II
Athlone
Athlone
R&D Manager
Galway
Galway
Senior Microbiologist
Dublin
Dublin
Principal Device Engineer
Dublin
Dublin
R&D Engineer
Galway
Galway
CTO
Galway
Galway
Material Handler
Carlow
Carlow
Quality Engineer
Athlone
Athlone
Principal Engineer
Dublin
Dublin
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Galway
Galway
Production Operator
Carlow
Carlow
Manufacturing Engineer
Galway
Galway
Maintenance Technician
Kilkenny
Kilkenny
Quality Specialist & Deputy RP
Limerick
Limerick
R&D Project Manager
Galway
Galway
Account Manager UK and Ireland
Republic of Ireland
Republic of Ireland
Production Operator
Meath
Meath
Quality Manager
Wexford
Wexford
Senior Project Engineer
Cavan
Cavan
Senior Quality Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Project Manager - R&D
Galway
Galway
Senior Engineering Manager
Limerick
Limerick
Product Development Engineer
Dublin
Dublin
Senior Design Engineer
Dublin
Dublin
MS&T Associate Director
Dublin
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
R&D Manager
Athlone
Athlone
Electronic Engineer
Dublin
Dublin
R&D Engineer
Dublin
Dublin
R&D Engineer
Galway
Galway
Injection Molding Engineer
North Leinster
North Leinster
Quality Control Technician
Carlow
Carlow
R&D Director
Galway
Galway
R&D Technician II
Galway
Galway
Electronic Engineer
Dublin
Dublin
Senior Operations Engineer
Galway
Galway
Senior QC Associate
Dublin
Dublin
Biomedical Engineer
Dublin
Dublin
Electronic Engineering
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Dublin
Quality Assurance Engineer
Longford
Longford
Senior Electronic Engineer
Dublin
Dublin
Senior Process Engineer
Dublin
Dublin
QC Bioanalytical Analyst
Dublin North
Dublin North
Lead Manufacturing Technician
Kilkenny
Kilkenny
Senior R&D Manager
Athlone
Athlone
Senior R&D Engineer
Dublin
Dublin
R&D Technician
Galway
Galway
Senior Operations Engineer
Galway
Galway
Graduate Manufacturing Technician
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Kilkenny
Staff Systems Engineer
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Limerick
Senior R&D Engineer
Galway
Galway
R&D Engineer
Galway
Galway
Injection Molding Engineer
North Leinster
North Leinster
Senior Design Engineer
Dublin
Dublin
Applications Scientist
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Quality Control Technician
Carlow
Carlow
Senior Equipment Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Quality Engineer
Galway
Galway
Project Engineer
Cork
Cork
Project Manager - R&D
Galway
Galway
Manufacturing Technician
Clare
Clare
Reg Affairs Specialist
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Connaught
Quality Engineer
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Galway
R&D Manager
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Connaught
R&D Engineer
Galway
Galway
Senior Electronics Engineer
Limerick
Limerick
Process Development Engineer
Galway
Galway
Principal Engineer - R&D
Galway
Galway
Senior R&D Engineer
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Senior Mechanical Engineer
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Medical Secretary
Cork
Cork
Injection Moulding Engineer
Athlone
Athlone
Quality Engineer
Athlone
Athlone
NPI Process Engineer
Carlow
Carlow
Product Development Manager
Galway
Galway
Senior QA Associate (Shift)
Dublin
Dublin
Validation Engineer
Athlone
Athlone
QA Validation Specialist
Meath
Meath
Production Operator
Dublin
Dublin
Senior R&D Project Manager
Galway
Galway
Product Development Engineer
Dublin
Dublin
Quality Technician
Dublin
Dublin
Microbiologist
Cork
Cork
Maintenance Technician
Carlow
Carlow
Senior Quality Engineer
Galway
Galway
Change Control SME
Cork
Cork
Process Engineer
Galway
Galway
Strategic Automation Lead
Waterford
Waterford
Quality Control NPI Senior Associate
Dublin South
Dublin South
Product Development Engineer II
Athlone
Athlone
Senior Operations Engineer
Galway
Galway
Medical Secretary
Cork
Cork
Quality Systems Manager
Dublin
Dublin
Quality Control Technician
Carlow
Carlow
Product Development Engineer
Dublin
Dublin
Project Scheduler
Louth
Louth
Electronic Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
R&D Engineer
Galway
Galway
R&D Manager
Connaught
Connaught
R&D Director
Galway
Galway
Senior R&D Manager/Director
Dublin
Dublin
Senior R&D Engineer
Clare
Clare
R&D Director
Galway
Galway
R&D Engineer
Galway
Galway
Injection Molding Engineer
North Leinster
North Leinster
R&D Engineer
Galway
Galway
Quality Engineer
Athlone
Athlone
Senior R&D Engineer
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Manufacturing Technician
Clare
Clare
R&D Engineer
Galway
Galway
Microbiology Manager
Dublin
Dublin
NPI Process Engineer
Carlow
Carlow
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
Quality Manager - NPI
Dublin
Dublin
Electronic Engineer
Dublin
Dublin
Product Development Engineer
Galway
Galway
Maintenance Technician
Carlow
Carlow
CTO
Dublin
Dublin
R&D Manager
Galway
Galway
R&D Engineer
Galway
Galway
Product Development Engineer II
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Athlone
R&D Engineer
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Galway
VP of Operations
Dublin
Dublin
QA Manager
Canada
Canada
R&D Program Manager
Dublin
Dublin
Reg Affairs Specialist
Connaught
Connaught
Principal R&D Engineer
Dublin
Dublin
Production Operator
Carlow
Carlow
Chief Medical Officer
Dublin
Dublin
Quality Specialist
Dublin
Dublin
QA Manager
Canada
Canada
Principal Engineer - R&D
Galway
Galway
Quality Specialist
Clare
Clare
Engineering Shift Technician
Dublin
Dublin
Quality Engineer
Galway
Galway
MS&T Bioprocess Engineer
Meath
Meath
Process Safety Specialist
Tipperary
Tipperary
Quality Specialist
Tipperary
Tipperary
Senior R&D Engineer
Galway
Galway
Senior Quality Engineer
Leitrim
Leitrim
Product Development Engineer
Galway
Galway
Quality Engineer
Galway
Galway
Responsible Person (RP)
Republic of Ireland
Republic of Ireland
Project Manager - R&D
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Product Development Engineer
Galway
Galway
Principal Process Equipment Engineer
Dublin South
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R&D Engineer
Galway
Galway
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
Head of R&D
Galway
Galway
Senior Quality Control Associate
Dublin South
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Senior Regulatory Affairs
Galway
Galway
Project Manager - R&D
Galway
Galway
Reliability Engineer
Tipperary
Tipperary
Injection Moulding Engineer
Athlone
Athlone
Senior QC 24/7 Shift
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
Electronic Design Engineer
Galway
Galway
EHS Systems Specialist
Dublin
Dublin
Quality Specialist
Clare
Clare
R&D Director
Galway
Galway
Program Manager
Dublin
Dublin
Quality Director
Galway
Galway
Senior Associate QC
Dublin
Dublin
Project Manager
Galway
Galway
EHS Specialist
Meath
Meath
Principal R&D Engineer
Dublin
Dublin
R&D Engineer
Clare
Clare
Principal R&D Engineer
Galway
Galway
Quality Systems Specialist
Tipperary
Tipperary
Engineering Projects Lead
Carlow
Carlow
Manufacturing Technician
Clare
Clare
Lead Project Engineer
Carlow
Carlow
Senior Quality Engineer-Remote
Republic of Ireland
Republic of Ireland
R&D Engineer
Galway
Galway
MS&T Associate Director
Dublin
Dublin
Utilities Engineer
Dublin
Dublin
Manufacturing Engineer
Galway
Galway
Senior Design Assurance Engineer
Athlone
Athlone
Electronic Engineer
Dublin
Dublin
Quality Engineer
Galway
Galway
Principal Data Architect
Limerick
Limerick
Production Operator
Dublin
Dublin
Senior Maintenance Technician
Roscommon
Roscommon
Production Operator
Meath
Meath
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
R&D Manager
Galway
Galway
Maintenance Technician
Kilkenny
Kilkenny
Quality Systems Specialist
Tipperary
Tipperary
Reliability Engineering Consultant - Rem
Republic of Ireland
Republic of Ireland
Design Assurance Engineer
Galway
Galway
R&D Manager
Connaught
Connaught
Senior Quality Engineer
Leitrim
Leitrim
Utilities Engineer - Black Utilities
Roscommon
Roscommon
Quality Operations Manager
Dublin
Dublin
Manufacturing Engineer
Wexford
Wexford
Medical Writer
Cork
Cork
Maintenance Reliability Engineer
Tipperary
Tipperary
Process Support Specialist
Carlow
Carlow
Manufacturing Engineer
Galway
Galway
Project Engineer
Cork
Cork
Production Operator
Carlow
Carlow
R&D Engineer
Galway
Galway
R&D Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
R&D Senior Program Manager
Galway
Galway
Principal Quality Engineer
Galway
Galway
Principal Engineer
Dublin
Dublin
R&D Manager
Dublin
Dublin
QC Laboratory Technician
Carlow
Carlow
Quality Manager
Galway
Galway
Quality Engineer
Wexford
Wexford
Senior R&D Engineer
Dublin
Dublin
Senior QC Microbiology
Dublin
Dublin
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
Compliance Specialist
Carlow
Carlow
Quality Engineer
Galway
Galway
R&D Engineer
Dublin
Dublin
Maintenance CMMS Engineer
Tipperary
Tipperary
Senior Quality Engineer
Dublin
Dublin
Senior Quality Engineer
Leitrim
Leitrim
Product Development Engineer
Dublin
Dublin
Senior R&D Manager
Athlone
Athlone
Mechanical Design Engineer
Germany
Germany
Production Operator
Meath
Meath
Territory Sales Specialist (Life Science
Belfast City
Belfast City
Senior Analytical Specialist
Limerick
Limerick
Manufacturing Technician
Clare
Clare
Quality Engineer
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Senior Manufacturing Manager
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Quality Engineer
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Galway
R&D Manager
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Galway
Senior R&D Engineer
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Search Results for Regulatory Affairs Executive
Job Title. | Location | Salary | Actions |
Reg Affairs SpecialistRole: 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, |
EU | Not Disclosed | |
Reg Affairs SpecialistRole: 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, |
EU | Not Disclosed | |
Reg Affairs SpecialistRole: 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, |
EU | Not Disclosed | |
Reg Affairs SpecialistRole: 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, |
EU | 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.
Pharma Sales Packaging Engineer Allied Healthcare Manufacturing Executive Project Manager Clinical Research Biopharmaceutical Quality Engineering Pharmaceutical Supply Chain Limerick Cork City Sales and Marketing Life Science Diagnostics Biotechnology Scientific Microbiology Chemistry Supply Chain Academic Scientist Medical Device Engineering IT Laboratory Scientist Quality Assurance Cork Academic Product Development Engineer Connected Health Sales and Marketing Quality Control Dublin Medical Affairs Mayo Validation Engineer PhD
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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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