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Cleaning Validation Engineer
Carlow
Carlow
Maintenance Technician
Kilkenny
Kilkenny
Senior Equipment Engineer
Dublin
Dublin
R&D Manager
Connaught
Connaught
Senior R&D Manager
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Dublin
Process Engineer
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Cork
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Republic of Ireland
Republic of Ireland
Quality Manager
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R&D Technician
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Biomedical Engineer
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Dublin
Electronic Engineer
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Applications Scientist
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Dublin
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Senior R&D Manager/Director
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Quality Engineer
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R&D Engineer
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Senior R&D Project Manager
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Senior R&D Engineer
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Senior Regulatory Affairs
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Reliability Engineer
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R&D Engineer
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Process Safety Specialist
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Clean Utilities Engineer
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QC Bioanalytical Analyst
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VP of Operations
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Manufacturing Technician
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Lead Project Engineer
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Project Engineer
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R&D Manager
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Staff Systems Engineer
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Head of R&D
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Lead Manufacturing Technician
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R&D Engineer
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Product Development Engineer
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Senior Quality Engineer
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Principal Process Equipment Engineer
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Quality Specialist
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Principal Engineer
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Production Manager
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Principal Engineer
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Project Manager - R&D
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Electronic Engineer
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Product Development Manager
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Manufacturing Technician
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Principal R&D Engineer
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Senior R&D Engineer
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Process Support Specialist
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Senior Validation Engineer
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R&D Manager
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Senior Project Engineer
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Embedded Software Engineer
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R&D Engineer
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Manufacturing Engineer
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Senior R&D Engineer-New Product Deve
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R&D Manager
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R&D Program Manager
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R&D Lifecycle Manager
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Senior R&D Engineer
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R&D Technician II
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EHS Systems Specialist
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Design Assurance Engineer
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Quality Engineer
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Strategic Automation Lead
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R&D Manager
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Product Development Engineer
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Principal Engineer
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Biostatistician
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Production Operator
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Project Manager
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Senior Quality Engineer
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Senior R&D Engineer
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Reg Affairs Specialist
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Project Engineer
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Quality Engineer
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Quality Engineer
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Principal R&D Engineer
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Electronic Design Engineer
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R&D Engineer
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Account Manager UK and Ireland
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Quality Director
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Quality Specialist
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Microbiology Manager
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Senior Operations Engineer
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Production Operator
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Program Manager
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Program Manager
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Director of Quality Engineering
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Maintenance Technician
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Project Manager
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Senior R&D Engineer
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Galway
Senior Procurement Associate
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Limerick
Medical Writer
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R&D Director
Galway
Galway
Electronic Engineer
Dublin
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Senior R&D Engineer
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Galway
Injection Moulding Engineer
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R&D Project Manager
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R&D Manager
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Production Operator
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Scientist (hybrid)
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Design Assurance Engineer
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Senior Project Engineer
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Quality Specialist
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Senior Quality Engineer
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Galway
Product Development Engineer
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Dublin
Process Engineer
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Galway
Project Manager - R&D
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Galway
R&D Manager
Galway
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Quality Systems Specialist
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Electronic Engineer
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Dublin
QA Specialist (Hybrid)
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Tipperary
Maintenance Technician
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Carlow
Design Assurance Engineer
Galway
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MS&T Bioprocess Engineer
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Senior Electronics Engineer
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Limerick
Senior Validation Engineer
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R&D Manager
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Senior Electronic Engineer
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Dublin
Senior Quality Engineer
Dublin
Dublin
Senior R&D Engineer
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Dublin
R&D Senior Program Manager
Galway
Galway
R&D Engineer
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
R&D Engineer
Galway
Galway
Responsible Person (RP)
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Quality Specialist
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Clare
Quality Technician
Dublin
Dublin
Quality Control Technician
Carlow
Carlow
Mechanical Design Engineer
Germany
Germany
Maintenance Reliability Engineer
Tipperary
Tipperary
Quality Engineer
Galway
Galway
Senior Design Engineer
Dublin
Dublin
Reg Affairs Specialist
Clare
Clare
R&D Engineer
Galway
Galway
Injection Molding Engineer
North Leinster
North Leinster
Quality Specialist
Dublin
Dublin
CAPA Specialist
Cavan
Cavan
R&D Manager
Galway
Galway
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
Program Manager
Galway
Galway
Senior Associate QC
Dublin
Dublin
R&D Technician II
Galway
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DeltaV Lead Automation Engineer
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Quality Engineer
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Production Operator
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Process Chemist
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Project Manager - R&D
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Senior R&D Engineer
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Maintenance Technician
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Kilkenny
Manufacturing Technician
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Clare
Senior R&D Manager
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Senior Design Engineer
Dublin
Dublin
Quality Engineer
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Senior Validation Engineer
Dublin
Dublin
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
Mechanical Engineer
Tipperary
Tipperary
Design Assurance Engineer
Galway
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QA Specialist (REMOTE)
Dublin
Dublin
Senior Electronics Engineer
Dublin
Dublin
Utilities Engineer
Dublin
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Maintenance Technician
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Kilkenny
Production Operator
Dublin
Dublin
Injection Moulding Engineer
Leitrim
Leitrim
Senior Manufacturing Manager
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Regulatory Associate
Cork
Cork
R&D Director
Galway
Galway
Manufacturing Engineer
Galway
Galway
Quality Specialist
Dublin
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Senior Quality Engineer
Galway
Galway
Manufacturing Engineer
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Galway
Principal R&D Engineer
Galway
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Qualified Person (Hybrid)
Tipperary
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Quality Technician
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Project Scheduler
Louth
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Senior Quality Engineer
Leitrim
Leitrim
Senior R&D Engineer
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Galway
Senior R&D Engineer
Dublin
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R&D Director
Galway
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Product Development Manager
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Senior Electronic Engineer
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Quality Engineer
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Change Control Lead
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Quality Engineer
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Senior Electrical Engineer
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R&D Manager
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Principal Software Engineer
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Validation Engineer
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Senior Quality Engineer-Remote
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QC Systems Specialist
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Engineering Projects Lead
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R&D Engineer
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Product Development Engineer
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Production Operator
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Senior R&D Engineer
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Search Results for Regulatory Affairs Executive
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 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 | |
Notified Body Product Assessor -Active DevicesProduct Assessor – Active Devices and SaMD Our client a global notified body is currently seeking a Product Assessor for their active and Software as a Medical Device portfolio. Reporting to Technical Business Development Director Business the product assessor will conduct technical documentation reviews against European Medical Device Directive and Medical Device Regulation for Class I/ IIa /IIb and/or Class III within the defined timeframe. This role sits in global group and provides a fantastic career opportunity to shape and develop the role. Su...Location: Canada, Outside EU, |
Canada | 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 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.
-
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.
-
Experience in writing and submitting regulatory documentation.
Scientific Quality Assurance Project Manager Scientist Dublin Cork City Academic Sales and Marketing Cork Laboratory Scientist Pharma Sales Sales and Marketing Diagnostics Quality Engineering Biotechnology PhD Validation Engineer Medical Device Life Science Allied Healthcare Supply Chain Pharmaceutical Supply Chain Biopharmaceutical Quality Control Microbiology Packaging Engineer Engineering Manufacturing Executive Connected Health Chemistry Product Development Engineer IT Clinical Research Limerick Academic Mayo Medical Affairs
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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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