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Validation Engineer
Limerick
Limerick
EHS Project Lead
Cavan
Cavan
Process Engineer
Limerick
Limerick
Project Manager - Suite Lead
Tipperary
Tipperary
Senior Validation Engineer
Limerick
Limerick
Senior R&D Engineer
Dublin
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Director of Quality Engineering
Limerick
Limerick
Principal R&D Engineer
Galway
Galway
Quality Validation Engineer
Limerick
Limerick
Electrical Engineer
Limerick
Limerick
Manufacturing Engineer
Galway
Galway
Lab Systems Specialist
Tipperary
Tipperary
Senior R&D Engineer
Galway
Galway
Senior Electronic Engineer
Dublin
Dublin
Aseptic Process Owner Lead
Dublin
Dublin
R&D Program Manager
Dublin
Dublin
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Biomedical Engineer
Dublin
Dublin
Biomedical Engineer
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Operations Lead
Dublin South
Dublin South
Planner/Scheduler
Cork
Cork
Embedded Software Engineer
Dublin
Dublin
Product Development Engineer
Galway
Galway
Maintenance Engineer
Cork
Cork
Process Support Specialist
Carlow
Carlow
Production Operator
Carlow
Carlow
Associate Global Trade Ops
Dublin
Dublin
Senior QC Associate
Dublin
Dublin
Senior Electrical Engineer
Galway
Galway
Manufacturing Engineer
Galway
Galway
Process Engineer (Shift)
Carlow
Carlow
Process Support Specialist
Carlow
Carlow
Pharmaceutical Consultant RP/RPi
United Kingdom
United Kingdom
Project Manager - R&D
Galway
Galway
Process Engineer
Galway
Galway
Maintenance CMMS Engineer
Tipperary
Tipperary
Project Engineer
Republic of Ireland
Republic of Ireland
Electrical Engineer
Cork
Cork
Maintenance Reliability Engineer
Tipperary
Tipperary
Senior Quality Engineer
Dublin
Dublin
Principal Process Equipment Engineer
Dublin South
Dublin South
Quality Engineer
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Engineering Business Manager
Dublin
Dublin
Product Development Engineer
Galway
Galway
Senior EHS Specialist
Louth
Louth
Aseptic Process Lead
Carlow
Carlow
Quality Manager - NPI
Dublin
Dublin
Project Process Engineer
Carlow
Carlow
Quality Engineer
Galway
Galway
Head of R&D
Galway
Galway
E&I Turnover Engineer
Carlow
Carlow
Project Engineer
Carlow
Carlow
Specialist Operations Engineer
Tipperary
Tipperary
Senior QA Associate - Operations
Limerick
Limerick
Senior Quality Engineer
Galway
Galway
Process Development Engineer
Galway
Galway
Senior Quality Engineer
Limerick
Limerick
Product Development Engineer
Galway
Galway
Quality Manager - NPI
Dublin
Dublin
Principal QA Associate
Limerick
Limerick
R&D Manager
Galway
Galway
Production Operator
Louth
Louth
C&Q Lead
Tipperary
Tipperary
Senior R&D Engineer
Galway
Galway
Embedded Software Engineer
Dublin
Dublin
Facilities Engineer
Carlow
Carlow
Quality Technician
Dublin
Dublin
QA Associate Specialist
Carlow
Carlow
Digital Lab Records Specialist
Tipperary
Tipperary
R&D Manager
Galway
Galway
Quality Systems Specialist
Galway
Galway
Maintenance Planner
Carlow
Carlow
Quality Manager
Dublin
Dublin
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
Quality Operations Specialist
Dublin North
Dublin North
Recruitment Consultant
Wexford
Wexford
Senior Engineering Manager
Limerick
Limerick
Distribution Centre Manager
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Quality Systems Manager
Dublin
Dublin
Clean Utilities Engineer
Carlow
Carlow
Quality Systems Enginer
Dublin
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Galway
Galway
Quality Technician
Carlow
Carlow
Manufacturing Engineer
Galway
Galway
Product Development Engineer
Dublin
Dublin
Biomedical Engineer
Dublin
Dublin
Process Engineer
Cork
Cork
Vigilance Assessor
Dublin
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Associate Quality Specialist
Tipperary
Tipperary
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
Senior R&D Engineer
Clare
Clare
Maintenance CMMS Engineer
Tipperary
Tipperary
Senior Quality Engineer
Galway
Galway
Trainer
Dublin
Dublin
Senior HVAC Engineer
Dublin
Dublin
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Clean Utilities Engineer
Carlow
Carlow
QC Chemistry Analyst (Shift)
Carlow
Carlow
Biomedical Engineer
Dublin
Dublin
Senior Validation Engineer
Limerick
Limerick
Principal R&D Engineer
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Dublin
Project Engineer
Clare
Clare
R&D Senior Program Manager
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Galway
Program Manager
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Cork
Engineering Shift Technician
Dublin
Dublin
Quality Engineer
Wexford
Wexford
Production Operator
Carlow
Carlow
E&I Turnover Engineer
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Carlow
Validation Engineer
Cork
Cork
Manufacturing Engineer
Wexford
Wexford
Project Engineer
Tipperary
Tipperary
Quality Technician
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Dublin
Senior Quality Engineer
Dublin
Dublin
Senior Validation Engineer
Dublin
Dublin
Senior QC Associate
Dublin
Dublin
Product Development Engineer
Galway
Galway
Project Manager
Limerick
Limerick
R&D Manager
Galway
Galway
Senior Regulatory Affairs
Galway
Galway
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Manufacturing Engineer
Limerick
Limerick
Maintenance Engineer
Carlow
Carlow
Associate Quality Specialist
Tipperary
Tipperary
Senior QC 24/7 Shift
Dublin
Dublin
Senior Quality Engineer
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Dublin
Engineering Manager
Clare
Clare
R&D Director
Galway
Galway
Senior Quality Engineer
Galway
Galway
Senior Electronic Engineer
Dublin
Dublin
Principal R&D Engineer
Galway
Galway
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
Senior Operations Manager
Tipperary
Tipperary
Validation Engineer
Carlow
Carlow
R&D Director
Galway
Galway
Project Engineer
Limerick
Limerick
QC Laboratory Technician
Carlow
Carlow
Senior R&D Engineer
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Dublin
Quality Manager
Dublin
Dublin
Suite Team Delivery Lead
Tipperary
Tipperary
Quality Specialist
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Tipperary
Senior R&D Engineer
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Medical Device Director
Republic of Ireland
Republic of Ireland
Project Engineer
Limerick
Limerick
R&D Manager
Galway
Galway
Quality Manager
Clare
Clare
Senior Quality Engineer
Galway
Galway
Chemical Engineer
Tipperary
Tipperary
Senior Quality Engineer-Remote
Republic of Ireland
Republic of Ireland
QA Associate - Materials Management
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Limerick
Engineering Projects Lead
Carlow
Carlow
Manufacturing Shift Lead
Donegal
Donegal
Product Development Engineer
Galway
Galway
Principal R&D Engineer
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Dublin
Senior Electronics Engineer
Dublin
Dublin
Facilities Engineer
Carlow
Carlow
Sourcing Specialist
Tipperary
Tipperary
Senior R&D Engineer
Clare
Clare
Senior R&D Engineer
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Dublin
Manufacturing Technician
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Galway
Galway
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R&D Director
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Carlow
Carlow
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Quality Engineer
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Senior Quality Engineer
Dublin
Dublin
Biomedical Engineer
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Dublin
Senior Validation Engineer
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Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Manufacturing Specialist
Dublin
Dublin
Recruitment Consultant
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Republic of Ireland
Responsible Person (RP)
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Republic of Ireland
EHS Systems Specialist
Dublin
Dublin
Automation Engineer
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Cavan
R&D Engineer
Dublin
Dublin
Senior R&D Project Manager
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Microbiology Manager
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Strategic Automation Lead
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Clinical Affairs Manager
Galway
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Senior R&D Manager/Director
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Dublin
R&D Director
Galway
Galway
CQV Lead
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Senior Associate Quality Control
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Dublin South
Quality Engineer
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Athlone
Change Control Coordinator
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Carlow
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Dublin
Packaging Engineer
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Dublin
Operations Specialist
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Search Results for Regulatory Affairs Manager
Job Title. | Location | Salary | Actions |
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 | |
Quality Manager - NPIRole: Quality Manager - NPI Based in Dun Laoghaire – on site role Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution, excellent opportunity to expand your career in exciting Medical Device company growing from strength to strength. Company: My client have deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. Job Purpose: To provide support for ISO9000/ISO13485 Quality System. Responsible for ensuring adherence to al...Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South, |
EU | Not Disclosed | |
Quality Manager - NPIRole: Quality Manager - NPI Based in Dun Laoghaire – on site role Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution, excellent opportunity to expand your career in exciting Medical Device company growing from strength to strength. Company: My client have deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. Job Purpose: To provide support for ISO9000/ISO13485 Quality System. Responsible for ensuring adherence to al...Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South, |
EU | Not Disclosed |
Regulatory Affairs Manager Career Profile
Regulatory Affairs Manager
This role is normally suited to someone with a minimum of 5 years in a Regulatory setting, ideally more. Management, departmental budgeting, training are some of the keys tasks involved on the non-technical side of the role.
Key Responsibilities
- Coordinating, compiling and submitting Marketing Authorisation variations for existing approvals
- Composing and reviewing Pre-IND information packages and NDA packages for registration of prescription products in the US through the FDA
- Liaise with partner companies as the primary Regulatory Affairs contact for the company to achieve product registration in all new worldwide regions within projected timeframes
- Regulatory Affairs European project team leader for all new projects
- Interpreting EU and US regulatory guidelines and procedures and ensuring the regulatory compliance of the company in all new regions Establish and analyse department budget
- Identify and recommend areas for cost savings from and Regulatory and compliance perspective
- Provide Regulatory advice and feedback for all internal company departments and external partners
- Maintain and apply a high level of awareness and understanding of the impact of existing and future planned regulations
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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
Valid XHTML - CSS