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Manufacturing Engineer
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Clare
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Graduate R&D Engineer
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Process Engineer
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Senior R&D Engineer
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Quality Technician
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Principal Process Equipment Engineer
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R&D Manager
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Process Support Specialist
Carlow
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Quality Systems Enginer
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Director of Quality Engineering
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Quality Manager - NPI
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Senior QC 24/7 Shift
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Clinical Affairs Manager
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Manager/ Senior Manager Drug Product Man
Republic of Ireland
Republic of Ireland
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Dublin
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QC Laboratory Technician
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Quality Manager - NPI
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Clean Utilities Engineer
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Production Operator
Carlow
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Principal R&D Engineer
Galway
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Project Engineer
Tipperary
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Process Support Specialist
Carlow
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Republic of Ireland
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Limerick
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Dublin South
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Aseptic Process Lead
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Principal R&D Engineer
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R&D Director
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Specialist Operations Engineer
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Biomedical Engineer
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Embedded Software Engineer
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Pharmacovigilance Manager (Remote)
Republic of Ireland
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Associate Director Quality Assurance
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QA Associate Specialist
Carlow
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Galway
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Technical Transfer Specialist - Remote
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Tipperary
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Carlow
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Qualified Person
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Trainer
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Galway
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QC Bioassay Analyst (shift)
Carlow
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Maintenance Engineer
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Chemical Engineer
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Medical Device Director
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Tipperary
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Clare
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Clare
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Carlow
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Meath
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Responsible Person (RP)
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Search Results for Regulatory Affairs Executive
Job Title. | Location | Salary | Actions |
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 SpecialistRegulatory Affairs Specialist (Remote/Hybrid) Our client a high potential start up medical device company currently seeks a Regulatory Affairs Specialist to join their team. Reporting to the Clinical and Regulatory Affairs Manager, the Regulatory Specialist will be responsible for helping with compliance to standards, regulatory submissions and annual reporting to the notified body and FDA. The Regulatory Affairs Specialist must have a working knowledge of medical device regulatory requirements and standard practices in the medical device industry. This position re...Location: Cork, |
Cork | Not Disclosed |
Regulatory Affairs Executive Career Profile
Regulatory Affairs Executive
The role concerns the filing and regulatory maintenance of Biopharmaceutical drug products. Depending on the company and the market authorisations for various drugs, Reg Affairs professionals will be required to deal with the IMB (Irish Medicines Board), MHRA (Medicines and Healthcare products regulatory Authority - UK) and FDA (Food & Drug Administration - US)Responsibilities
- Life cycle management and Maintenance of regulatory filings including annual reports and supplements to US FDA.
- Preparation of registration submissions, in CTD (Clinical Trial Dossier) format, for biopharmaceutical products for approval by the US FDA, European Regulatory Authorities and worldwide, as required.
- Monitoring the progress of registration submissions, responding to queries and ensuring that registration approvals are granted without undue delays.
- Regulatory Compliance, for change control activities monitoring the impact of changes in regulatory submissions.
- Monitoring adverse events for submissions, preparation and review and generation of supporting documents for potential field alerts and recalls.
- Maintenance of approvals, including the preparation of annual reports for US products.
- Assess and review documentation to ensure compliance with product licences.
- Undertake general regulatory activities that interface with other departments such as Manufacturing, Product Development, Quality Control and Quality Assurance.
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Actively participate in project teams, as required.
Qualifications / Experience
- Minimum of 3 years regulatory experience in the pharmaceutical industry.
- Knowledge of the current regulatory requirements, particularly US and EU.
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Experience in writing and submitting regulatory documentation.
Sales and Marketing Allied Healthcare Mayo Biotechnology Pharma Sales Quality Control Medical Device Validation Engineer Scientist Chemistry Supply Chain Connected Health Life Science Pharmaceutical Quality Engineering Limerick Clinical Research IT Cork City Diagnostics PhD Academic Sales and Marketing Microbiology Scientific Product Development Engineer Academic Laboratory Scientist Medical Affairs Dublin Cork Packaging Engineer Biopharmaceutical Project Manager Engineering Supply Chain Quality Assurance Manufacturing Executive
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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