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Search Results for Regulatory Affairs Clinical Research
Job Title. | Location | Salary | Actions |
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.
Research Fellow Westmeath QA RA Engineer Regulatory Affairs EHS Engineer Research and Development Healthcare Microbiology Senior Research and Development Engineer Validation Specialist Dublin Regulatory Affairs Executive Quality Assurance Limerick City EHS Specialist Roscommon Supply Chain QA Validation Specialist Senior Project Manager Contract Supplier Quality Engineer R and D Manager Snr Validation Engineer Galway Medical Device Engineering Engineering Manager QE Manufacturing Engineer Supply Chain Quality Engineer Quality Systems Engineer Kildare Republic of Ireland QA Specialist QA Manager Quality Systems Lead Clare Quality Systems Specialist Galway City Quality Specialist Quality Manager Validation Engineer Design Assurance Medical Affairs Regulatory Affairs Officer Midlands Biopharmaceutical Technical Specialist Athlone Connaught Life Science Snr R and D Engineer Offaly Regulatory Affairs Specialist Regulatory Affairs Director BD Manager Connected Health R and D Director Limerick Longford Contract Business Development Executive Pharmaceutical Life Science Manufacturing and Technology Manager Senior Regulatory Affairs Officer QA Engineer Regulatory Affairs Manager Lead Quality Engineer Clinical Research Regulatory Affairs Consultant Regulatory Affairs Clinical Research Biotechnology Engineering Sligo Senior Quality Engineer Leitrim Regulatory Affairs Scientific Project Manager Cork
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Regulatory Affairs | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected]
Copyright © 2012 Life Science Recruitment Ltd
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Regulatory Affairs | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected]
Copyright © 2012 Life Science Recruitment Ltd
This site uses cookies. For more information on our cookie policy read our Privacy Policy | Terms of Use
Registered as a private limited company. No: 445328 | Web Design / SEO by WebScience | Valid XHTML - CSS







