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Injection Molding Engineer
North Leinster
North Leinster
Project Manager - R&D
Galway
Galway
Accreditation Manager
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Clare
Clare
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Carlow
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Senior Project Engineer
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Cavan
Senior R&D Engineer
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R&D Engineer
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Galway
Lead Manufacturing Technician
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Kilkenny
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Galway
Senior Recruitment Consultant
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MS&T Associate Director
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Electronic Design Engineer
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Biomedical Engineer
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R&D Manager
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Senior R&D Engineer
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Principal R&D Engineer
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Project Manager
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Senior R&D Engineer
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Mechanical Technician
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Product Development Engineer II
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Clean Utilities Engineer
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Project Manager
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QC Laboratory Technician
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Design Assurance Engineer
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Injection Molding Engineer
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Program Manager
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R&D Manager
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Senior R&D Engineer
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Senior Regulatory Affairs Specialist
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VP of Operations
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Project Manager - Technical Transfer
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Project Engineer
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Electronic Engineer
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Senior Electronic Engineer
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R&D Engineer
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CTO
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Quality Engineer
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Quality Assurance Engineer
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Senior R&D Engineer
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Quality Manager
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Quality Engineer
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Senior Quality Engineer
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Senior R&D Engineer
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Senior R&D Manager/Director
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Principal Engineer
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Scientist (hybrid)
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Design Assurance Engineer
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Validation Engineer
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R&D Director
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Purchasing & Planning Manager
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Process Engineer
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Product Development Engineer II
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Change Control SME
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R&D Manager
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Design Assurance Engineer
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R&D Manager
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Regulatory Associate
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E&I Turnover Engineer
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Qualified Person (Hybrid)
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Quality Control Technician
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R&D Manager
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Project Manager
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Senior R&D Engineer
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CAPA Specialist
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R&D Technician II
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Reliability Engineering Consultant - Rem
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Republic of Ireland
Senior Microbiologist
Dublin
Dublin
Field Service Engineer (Chromatography e
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R&D Director
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Senior Quality Engineer-Remote
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Project Manager - R&D
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Facilities Engineer
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Carlow
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Senior R&D Engineer
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Galway
Quality Engineer
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Project Engineer
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Production Operator
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Applications Scientist
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Product Development Engineer
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Compliance Specialist
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Material Handler
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Senior Design Engineer
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Cleaning Validation Engineer
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Senior Quality Engineer
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Senior R&D Engineer
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R&D Manager
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Galway
R&D Director
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Galway
Cleaning Validation Engineer
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Carlow
Product Development Engineer II
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Senior Maintenance Technician
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Kilkenny
R&D Technician II
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Galway
Quality Engineer
Galway
Galway
R&D Director
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Galway
Program Manager
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Production Operator
Carlow
Carlow
R&D Project Manager
Galway
Galway
Maintenance Technician
Kilkenny
Kilkenny
Senior Process Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
R&D Senior Program Manager
Galway
Galway
Production Operator
Carlow
Carlow
Product Development Engineer
Dublin
Dublin
Process Safety Specialist
Tipperary
Tipperary
R&D Engineer
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Quality Systems Specialist
Tipperary
Tipperary
Injection Moulding Engineer
Athlone
Athlone
Senior R&D Engineer
Galway
Galway
Principal R&D Engineer
Dublin
Dublin
Electronic Engineer
Dublin
Dublin
Senior Quality Engineer
Leitrim
Leitrim
R&D Technician
Galway
Galway
Project Manager - R&D
Galway
Galway
Senior Regulatory Affairs
Galway
Galway
Project Engineer
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Clare
Production Operator
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Meath
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Dublin
Quality Director
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Galway
Senior R&D Engineer
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Galway
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Tipperary
R&D Engineer
Galway
Galway
Quality Specialist
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Clare
R&D Manager
Galway
Galway
Product Development Engineer
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Dublin
Maintenance Technician
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Kilkenny
Reg Affairs Specialist
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Clare
Reg Affairs Specialist
Clare
Clare
Head of R&D
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Galway
Senior Validation Engineer
Carlow
Carlow
Production Operator
Dublin
Dublin
Quality Engineer
Galway
Galway
Electronic Engineer
Dublin
Dublin
QA Manager
Canada
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Principal Device Engineer
Dublin
Dublin
Quality Manager - Medical Devices
Limerick City
Limerick City
Maintenance CMMS Engineer
Tipperary
Tipperary
Senior Operations Engineer
Galway
Galway
R&D Engineer
Galway
Galway
Biomedical Engineer
Dublin
Dublin
Manufacturing Engineer
Galway
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Quality Manager - NPI
Dublin
Dublin
Senior Design Assurance Engineer
Athlone
Athlone
R&D Manager
Athlone
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R&D Manager
Galway
Galway
Quality Specialist
Dublin
Dublin
Regulatory Affairs Maanger
Galway
Galway
R&D Engineer
Dublin
Dublin
Senior R&D Manager
Athlone
Athlone
Senior R&D Engineer
Galway
Galway
Injection Molding Engineer
North Leinster
North Leinster
Senior Quality Engineer
Dublin
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Principal Software Engineer
Athlone
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MS&T Bioprocess Engineer
Meath
Meath
Production Operator
Carlow
Carlow
Production Manager
Dublin
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Senior Electrical Engineer
Galway
Galway
Senior Design Engineer
Dublin
Dublin
Electronic Engineer
Dublin
Dublin
Production Operator
Meath
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R&D Manager
Galway
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QC Bioanalytical Analyst
Dublin North
Dublin North
Project Scheduler
Louth
Louth
Manufacturing Engineer
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Reliability Engineer
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CTO
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Quality Control Technician
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Senior Quality Engineer
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Technical Administrator
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Manufacturing Engineer
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Galway
Product Development Engineer
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Galway
Quality Engineer
Galway
Galway
Senior Operations Engineer
Galway
Galway
Design Assurance Engineer
Galway
Galway
Electronic Engineering
Dublin
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QA Specialist (Shift days)
Dublin
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Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Lead Manufacturing Technician
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Quality Engineer
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Responsible Person (RP)
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Lead Project Engineer
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Senior R&D Engineer
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Principal Engineer
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Search Results for Regulatory Affairs Clinical Research
Job Title. | Location | Salary | Actions |
Reg Affairs SpecialistJob title: 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. Responsibilities...Location: Clare, Galway, Galway City, Limerick, Limerick City, |
EU | Not Disclosed | |
Reg Affairs SpecialistJob title: 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. Responsibilities...Location: Clare, Galway, Galway City, Limerick, Limerick City, |
EU | Not Disclosed | |
Regulatory AssociateRole: Regulatory Associate Location: Bishopstown, Cork Benefits: Top salary, Hybrid working, bonus, pension and healthcare Company: My client are an innovative Cork-based med‑tech spin‑out disrupting paediatric ENT care with a streamlined, in‑office ear‑tube insertion device. They've scaled from Irish clinical success to U.S. regulatory approval and global roll‑out under a German multinational company. With a strong IP portfolio, seasoned leadership, and growing market presence, they&rs...Location: Cork, |
Cork | 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 | |
Associate Director - Global Core Labeling (Regulatory Affairs)Associate Director - Global Core Labeling (Regulatory Affairs) Our client is a global healthcare leader with employees around the world who work to discover and bring life-changing medicines to those who need them. They are seeking a Global Labelling Lead who shall be at Associate Director level to join a growing team of Regulatory professionals within their Global Business Centre.The purpose of the Associate Director, Global Regulatory Affairs (GRA) Global Core Labeling role is to lead the development and maintenance of global labeling, including all core labelin...Location: Cork, |
Cork | 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 Clinical Research Career Profile
Regulatory Affairs Clinical Research
Working in a CRO (Clinical Research Organisation) means working on large projects simultaneously. The regulatory filing for every stage of the clinical trial needs to be looked after for progress on the drug to be made. Below is an example Spec for a Senior role in a CRO:
Key Responsibilities
- Liaise directly with regulatory bodies such as EMA & National Competent Authorities and you will maintain relations with key contacts
- Work as part of the EMEA Regulatory team.
- Evaluate data, review documentation and support/prepare documentation for medicinal products and medicals devices, as appropriate, for all stages of product development i.e. CTA through to life cycle maintenance
- Maintain an accurate record of the time and direct costs associated with each project for which you are responsible and where appropriate produce status reports.
- You will support the Regulatory Project Lead and dependent on the size of and nature of the project assigned, you may act as the Regulatory Project Lead and you will deal directly with the sponsor and Regulatory Agencies
- Control all project related documentation either in paper or electronic form.
Skills / Experience
- Must have 4-5 Yrs in a similar position.
- Must have a science degree in a related field.
- Knowledge of European guidelines and be able to review and evaluate CMC, Pre-Clinical and/or Clinical data in compliance with the relevant guidance.
- Excellent communication and interpersonal skills, both written and verbal enabling you to deal with queries in a timely manner.
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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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