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Quality Engineer
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Galway
Senior Validation Engineer
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Product Development Engineer
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Senior Engineering Manager
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Principal Engineer - R&D
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Electronic Engineer
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Germany
Process Development Engineer
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Galway
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Head of R&D
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Project Manager - R&D
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Senior Project Engineer
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Principal R&D Engineer
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Senior Quality Control Associate
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Senior R&D Engineer
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QA Manager
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Principal Device Engineer
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Quality Director
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Senior R&D Engineer
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R&D Engineer
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R&D Engineer
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Senior Manufacturing Manager
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VP of Operations
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R&D Director
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Material Handler
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Quality Operations Manager
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R&D Manager
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Senior Quality Engineer
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Principal Software Engineer
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Athlone
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Galway
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Quality Engineer
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Senior Electronic Engineer
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Director of Quality Engineering
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CTO
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Principal Process Equipment Engineer
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QC Laboratory Technician
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Project Engineer
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Senior Validation Engineer
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Process Engineer
Galway
Galway
Senior R&D Engineer
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Sourcing Specialist
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Electronic Engineering
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Program Manager
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QA Specialist (Shift days)
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Dublin
Regulatory Associate
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R&D Manager
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Galway
R&D Manager
Connaught
Connaught
R&D Manager
Connaught
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Senior R&D Engineer
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Galway
Injection Molding Engineer
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North Leinster
Scientist (hybrid)
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Project Manager - R&D
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Staff Systems Engineer
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R&D Director
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EHS Systems Specialist
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Quality Control Technician
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Quality Assurance Engineer
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QA Engineer
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Senior Electronic Engineer
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QC Bioanalytical Analyst
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Dublin North
Senior R&D Project Manager
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Galway
Senior Quality Engineer
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Dublin
R&D Technician II
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Process Chemist
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R&D Program Manager
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Dublin
Senior R&D Engineer
Galway
Galway
EHS Specialist
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Meath
Quality Manager - NPI
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Dublin
MS&T Associate Director
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Dublin
Project Manager
Galway
Galway
R&D Engineer
Galway
Galway
Quality Control Technician
Carlow
Carlow
Quality Systems Specialist
Tipperary
Tipperary
R&D Engineer
Galway
Galway
Senior Electronic Engineer
Dublin
Dublin
Senior Quality Engineer
Leitrim
Leitrim
R&D Engineer
Galway
Galway
Reg Affairs Specialist
Connaught
Connaught
Production Operator
Carlow
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Production Operator
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Quality Specialist
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Design Assurance Engineer
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Quality Specialist
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Process Support Specialist
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Quality Specialist
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R&D Engineer
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R&D Manager
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Mechanical Technician
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Production Operator
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Search Results for Regulatory Affairs Clinical Research
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 | |
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 | |
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 | |
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.
IT Pharmaceutical Limerick Scientific PhD Biopharmaceutical Life Science Medical Affairs Pharma Sales Supply Chain Supply Chain Biotechnology Manufacturing Executive Microbiology Mayo Connected Health Project Manager Dublin Cork City Engineering Allied Healthcare Academic Diagnostics Sales and Marketing Validation Engineer Product Development Engineer Chemistry Sales and Marketing Quality Engineering Academic Packaging Engineer Clinical Research Medical Device Scientist Laboratory Scientist Quality Assurance Cork Quality Control
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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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