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Senior Quality Engineer
Leitrim
Leitrim
Design Assurance Engineer
Galway
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Quality Control Technician
Carlow
Carlow
Senior R&D Engineer
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Galway
Biostatistician
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R&D Engineer
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Senior Associate QC
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Senior R&D Engineer
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R&D Technician II
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Head of R&D
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Qualified Person (Hybrid)
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Product Development Engineer
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Project Manager
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Senior Mechanical Engineer
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R&D Manager
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R&D Director
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Principal Software Engineer
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Electronic Engineer
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Quality Engineer
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Product Development Manager
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R&D Manager
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Senior R&D Manager
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Product Development Engineer
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Project Engineer
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Manufacturing Technician
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Operations Engineer
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Production Operator
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R&D Engineer
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Principal Device Engineer
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Facilities Engineer
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Senior Quality Engineer
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Quality Engineer
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R&D Manager
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R&D Manager
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Senior R&D Engineer
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Principal Engineer
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QA Specialist (REMOTE)
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R&D Lifecycle Manager
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Electronic Engineer
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Quality Director
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Senior R&D Engineer
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Senior R&D Engineer
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Senior R&D Manager/Director
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Material Handler
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Mechanical Engineer
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Principal Process Equipment Engineer
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Senior Regulatory Affairs
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Utilities Engineer
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QC Bioanalytical Analyst
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Production Operator
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MS&T Bioprocess Engineer
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Senior Operations Engineer
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Product Development Engineer
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Senior Design Engineer
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Accreditation Manager
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Staff R&D Engineer
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Electronic Engineer
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Principal Engineer
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Engineering Projects Lead
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Senior Validation Engineer
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Regulatory Affairs Maanger
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Quality Engineer
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Field Service Engineer (Chromatography e
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Validation Engineer
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R&D Engineer
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Senior Quality Engineer
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Account Manager UK and Ireland
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MS&T Associate Director
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Principal R&D Engineer
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Maintenance Technician
Carlow
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Production Operator
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Carlow
Injection Moulding Engineer
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Athlone
QC Systems Specialist
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Investigation Lead
Dublin
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R&D Engineer
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Chief Medical Officer
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Senior Quality Engineer
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Design Assurance Engineer
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Galway
Quality Engineer
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Cleaning Validation Engineer
Carlow
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Quality Technician
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Project Engineer
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Cork
R&D Engineer
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Galway
R&D Director
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Senior Quality Engineer
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Maintenance Technician
Kilkenny
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Senior R&D Engineer
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Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Senior R&D Engineer
Dublin
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Senior Quality Engineer
Dublin
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Senior Quality Engineer
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Product Development Engineer
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QA Specialist (Hybrid)
Tipperary
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Injection Moulding Engineer
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Dublin
Product Development Engineer
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Dublin
Reliability Engineer
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Maintenance CMMS Engineer
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Tipperary
Quality Systems Manager
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Dublin
Clean Utilities Engineer
Carlow
Carlow
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Senior Equipment Engineer
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Principal R&D Engineer
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Dublin
R&D Manager
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Embedded Software Engineer
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Senior R&D Engineer
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Galway
Project Engineer
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Design Assurance Engineer
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Quality Manager
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Galway
R&D Engineer
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Galway
R&D Manager
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Galway
Electronic Engineer
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Maintenance Technician
Carlow
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Injection Molding Engineer
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R&D Engineer
Galway
Galway
Senior Manufacturing Manager
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Project Manager - R&D
Galway
Galway
Senior R&D Engineer
Galway
Galway
Manufacturing Technician
Clare
Clare
Quality Specialist
Clare
Clare
R&D Manager
Galway
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QA Specialist (Shift days)
Dublin
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Senior Validation Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Electronic Engineer
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Project Manager - R&D
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R&D Engineer
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Quality Control NPI Senior Associate
Dublin South
Dublin South
Maintenance Reliability Engineer
Tipperary
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Principal Engineer
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Regulatory Associate
Cork
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R&D Engineer
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R&D Engineer
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Quality Engineer
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Senior R&D Engineer
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Lead Manufacturing Technician
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Senior Electronic Engineer
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Responsible Person (RP)
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R&D Manager
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R&D Manager
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Search Results for Regulatory Affairs Specialist
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 | |
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 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 | |
Senior Regulatory Affairs SpecialistSenior Regulatory Affairs Specialist Our client a Medical Device Multinational currently seeks a Senior Regulatory Specialist to join their team. The Senior. Regulatory Affairs Specialist will develop strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction. The Sr. Regulatory position will assist in mentoring and development of staff members as part of the role. Role/Responsibilities • Manage Technical Documentation ...Location: Westmeath, |
Westmeath | Not Disclosed |
Regulatory Affairs Specialist Career Profile
Regulatory Affairs Specialist
There are Regulatory Affairs (RA) opportunities available in a variety of industries: Pharmaceutical / Biotech / Agrochemical / Clinical Research Organisations (CRO's). There also exist roles in Consultancy organisations, companies which service small and large Clients in the above industries, on various projects. These can often be interesting and varied roles for the experienced RA professional.Salary Scale:
- Regulatory Affairs Assistant - €25,000 - €28,000
- Regulatory Affairs Officer - €32,000 - €39,000
- Regulatory Affairs Specialist - €40,000 - €55,000
- Regulatory Affairs Manager - €60,000 - €80,000
- Regulatory Affairs Director - €85,000 +
Role 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 pharmaceutical 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.
Industry 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.
PhD Pharma Sales Dublin Mayo Supply Chain Manufacturing Executive Medical Affairs Supply Chain Biopharmaceutical Cork Microbiology Academic Quality Control Quality Engineering Packaging Engineer Sales and Marketing Engineering Connected Health Laboratory Scientist Allied Healthcare Chemistry Clinical Research Life Science Pharmaceutical Medical Device Project Manager Diagnostics Quality Assurance IT Limerick Sales and Marketing Product Development Engineer Biotechnology Scientific Cork City Academic Scientist Validation Engineer
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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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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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