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Biomedical Engineer
Dublin
Dublin
QA Specialist
Cork
Cork
Senior R&D Engineer
Dublin
Dublin
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
QC Bioassay Analyst (shift)
Carlow
Carlow
Manufacturing Specialist
Dublin
Dublin
Product Development Engineer
Galway
Galway
Automation Engineer
Cavan
Cavan
Senior Quality Engineer
Dublin
Dublin
Associate Quality Specialist
Tipperary
Tipperary
Senior Quality Engineer
Galway
Galway
Principal R&D Engineer
Galway
Galway
QA Associate Specialist
Carlow
Carlow
Senior Quality Engineer-Remote
Republic of Ireland
Republic of Ireland
Senior Quality Engineer
Limerick
Limerick
C&Q Lead
Tipperary
Tipperary
Occupational Hygiene Consultant
Kildare
Kildare
R&D Director
Galway
Galway
Quality Manager
Clare
Clare
R&D Director
Galway
Galway
Quality Systems Manager
Dublin
Dublin
Clinical Affairs Manager
Galway
Galway
Quality Engineer
Athlone
Athlone
Principal Process Equipment Engineer
Dublin South
Dublin South
R&D Director
Galway
Galway
Senior Engineering Manager
Limerick
Limerick
Senior R&D Engineer
Galway
Galway
R&D Manager
Galway
Galway
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Quality Engineer
Galway
Galway
Packaging Engineer
Dublin
Dublin
Suite Team Delivery Lead
Tipperary
Tipperary
Engineering Manager
Clare
Clare
Change Control Coordinator
Carlow
Carlow
Clean Utilities Engineer
Carlow
Carlow
Principal QA Associate
Limerick
Limerick
R&D Director
Galway
Galway
R&D Manager
Galway
Galway
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Senior Validation Engineer
Dublin
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Production Operator
Carlow
Carlow
Product Development Engineer
Galway
Galway
R&D Senior Program Manager
Galway
Galway
Product Development Engineer
Galway
Galway
Engineering Projects Lead
Carlow
Carlow
Clean Utilities Engineer
Carlow
Carlow
Quality Manager
Dublin
Dublin
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Responsible Person (RP)
Republic of Ireland
Republic of Ireland
Senior Quality Engineer
Galway
Galway
Senior R&D Engineer
Galway City
Galway City
Quality Systems Enginer
Dublin
Dublin
Electrical Engineer
Cork
Cork
Technical Support Scientist
Longford
Longford
Validation Engineer
Limerick
Limerick
Strategic Automation Lead
Waterford
Waterford
Senior Mechanical Engineer
Dublin
Dublin
Associate Global Trade Ops
Dublin
Dublin
Manufacturing Engineer
Wexford
Wexford
Principal R&D Engineer
Dublin
Dublin
Biomedical Engineer
Dublin
Dublin
Quality Specialist
Tipperary
Tipperary
Maintenance Engineer
Carlow
Carlow
Process Engineer
Galway
Galway
Process Engineer
Limerick
Limerick
Quality Systems Specialist
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Validation Engineer
Carlow
Carlow
Quality Validation Engineer
Limerick
Limerick
Senior R&D Engineer
Galway
Galway
Quality Engineer
Athlone
Athlone
Microbiology Analyst
Dublin
Dublin
QC Laboratory Technician
Carlow
Carlow
Electrical Engineer
Limerick
Limerick
Recruitment Consultant
Republic of Ireland
Republic of Ireland
Pharmaceutical Consultant RP/RPi
United Kingdom
United Kingdom
Senior Validation Engineer
Limerick
Limerick
Senior QC 24/7 Shift
Dublin
Dublin
Process Engineer (Shift)
Carlow
Carlow
Program Manager
Cork
Cork
Planner/Scheduler
Cork
Cork
Biostatistician
Cork
Cork
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Senior Quality Engineer
Dublin
Dublin
Medical Device Director
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Dublin
Dublin
Microbiology Manager
Dublin
Dublin
R&D Program Manager
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Principal R&D Engineer
Galway
Galway
Sourcing Specialist
Tipperary
Tipperary
Senior R&D Engineer
Galway
Galway
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Senior Regulatory Affairs
Galway
Galway
Manufacturing Engineer
Galway
Galway
Senior R&D Manager/Director
Dublin
Dublin
Aseptic Process Owner Lead
Dublin
Dublin
Warehouse Operator (Shift)
Carlow
Carlow
Senior Technical Writer
Dublin
Dublin
Senior R&D Engineer
Clare
Clare
Distribution Centre Manager
Dublin
Dublin
Maintenance CMMS Engineer
Tipperary
Tipperary
Project Engineer
Republic of Ireland
Republic of Ireland
Project Manager - Suite Lead
Tipperary
Tipperary
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
Product Development Engineer
Galway
Galway
Senior EHS Specialist
Louth
Louth
Chemical Engineer
Tipperary
Tipperary
Process Support Specialist
Carlow
Carlow
Quality Manager - NPI
Dublin
Dublin
Senior Electronics Engineer
Dublin
Dublin
Biomedical Engineer
Dublin
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
EHS Project Lead
Cavan
Cavan
Senior R&D Engineer
Galway
Galway
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
Maintenance Engineer
Cork
Cork
Process Development Engineer
Galway
Galway
Digital Lab Records Specialist
Tipperary
Tipperary
Project Engineer
Clare
Clare
Senior Validation Engineer
Limerick
Limerick
Project Manager
Limerick
Limerick
Senior R&D Engineer
Dublin
Dublin
Senior Electrical Engineer
Galway
Galway
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
Senior Quality Engineer
Dublin
Dublin
Product Development Engineer
Galway
Galway
Quality Manager
Dublin
Dublin
Senior QC Associate
Dublin
Dublin
E&I Turnover Engineer
Carlow
Carlow
Project Engineer
Limerick
Limerick
Senior Quality Engineer
Galway
Galway
Head of R&D
Galway
Galway
R&D Manager
Galway
Galway
Process Engineer
Cork
Cork
Quality Technician
Carlow
Carlow
Manufacturing Technician
Clare
Clare
Senior QA Associate - Operations
Limerick
Limerick
Senior Mechanical Engineer
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
Operations Specialist
Louth
Louth
R&D Manager
Galway
Galway
Aseptic Process Lead
Carlow
Carlow
Manufacturing Engineer
Limerick
Limerick
Product Development Engineer
Dublin
Dublin
QA Associate - Materials Management
Limerick
Limerick
E&I Turnover Engineer
Carlow
Carlow
Maintenance CMMS Engineer
Tipperary
Tipperary
Recruitment Consultant
Wexford
Wexford
Senior R&D Engineer
Dublin
Dublin
Facilities Engineer
Carlow
Carlow
Senior Electronic Engineer
Dublin
Dublin
Specialist Operations Engineer
Tipperary
Tipperary
Project Process Engineer
Carlow
Carlow
Manufacturing Engineer
Galway
Galway
Principal R&D Engineer
Dublin
Dublin
Senior R&D Project Manager
Galway
Galway
Engineering Shift Technician
Dublin
Dublin
Maintenance Reliability Engineer
Tipperary
Tipperary
Analytical Chemist
Tipperary
Tipperary
Process Support Specialist
Carlow
Carlow
Quality Operations Specialist
Dublin North
Dublin North
Production Operator
Louth
Louth
QC Chemistry Analyst (Shift)
Carlow
Carlow
Validation Engineer
Cork
Cork
Engineering Business Manager
Dublin
Dublin
Production Planner
Meath
Meath
Process Support Specialist
Carlow
Carlow
Production Operator
Carlow
Carlow
Facilities Engineer
Carlow
Carlow
Project Engineer
Tipperary
Tipperary
Quality Manager - NPI
Dublin
Dublin
Senior QC Associate
Dublin
Dublin
Project Engineer
Limerick
Limerick
R&D Engineer
Dublin
Dublin
Project Manager - R&D
Galway
Galway
Senior Electronic Engineer
Dublin
Dublin
Senior Validation Engineer
Dublin
Dublin
Director of Quality Engineering
Limerick
Limerick
Embedded Software Engineer
Dublin
Dublin
Project Engineer
Carlow
Carlow
Senior R&D Engineer
Clare
Clare
Electronic Design Engineer
Galway
Galway
Quality Engineer
Wexford
Wexford
Biomedical Engineer
Dublin
Dublin
Trainer
Dublin
Dublin
CQV Lead
Tipperary
Tipperary
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Other similar job titles you may be intertested in include:
Compliance Specialist
Senior Regulatory Affairs Officer
Regulatory Affairs
Regulatory Affairs Executive
Registration Officer
Regulatory Affairs Specialist
Please view a sample career profile in the box below
or click here to browse all open vacancies
Regulatory Affairs Officer Career Profile
Regulatory Affairs Officer
The Regulatory Affairs (RA) department is tasked with ensuring that the company complies with all of the local and international regulations and laws pertaining to their business. The Regulatory Affairs Officer works with international, state and local regulatory agencies, such as the Irish Medicines Board (IMB), the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) on specific issues affecting their business. The Regulatory Affairs Officer advises the company on the current regulatory aspects and climate that would affect proposed activities. The RA Officer has many interactions within the medical affairs dept. including medical information, pharmacovigilance and clinical trials.
Key responsibilities of the Regulatory Affairs Officer
- Maintenance of Irish and overseas licenses including preparation of variation and renewal applications as appropriate.
- Preparation and submission of Marketing Authorisation applications to EU regulatory authorities.
- Preparation of dossiers to obtain CE marking for medical devices.
- Ensuring Labelling complies with appropriate legislation.
- Ensure approved regulatory requirements are enforced in-house.
- Participate in the development of electronic submission of dossiers.
- Provide support to R&D projects; including new product introductions, changes to existing products and processes.
- Liaise with suppliers, clients, development partners and regulatory bodies.
- Ensure guidelines and knowledge of legislation is current and be able to advise of future developments and changes.
- Monitor the process of regulatory submissions, responding to queries and ensuring that registration approvals are granted without undue delay.
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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