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Electronic Engineer
Dublin
Dublin
Quality Engineer
Galway
Galway
Senior R&D Manager
Athlone
Athlone
Senior R&D Engineer
Clare
Clare
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MS&T Bioprocess Engineer
Meath
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Reg Affairs Specialist
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Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
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Quality Specialist
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Change Control Lead
Tipperary
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R&D Manager
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Senior R&D Engineer
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Director of Quality Engineering
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Senior Validation Engineer
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Quality Technician
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QA Specialist (REMOTE)
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Electronic Engineer
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Process Engineer
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R&D Manager
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Investigation Lead
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Medical Writer
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Principal Engineer
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Qualified Person (Hybrid)
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Product Development Engineer II
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Scientist (hybrid)
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Senior Electronic Engineer
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Senior R&D Engineer
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R&D Manager
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Principal R&D Engineer
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Product Development Engineer II
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Production Operator
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Quality Systems Specialist
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Quality Control NPI Senior Associate
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Design Assurance Engineer
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Maintenance CMMS Engineer
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Purchasing & Planning Manager
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Senior Maintenance Technician
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R&D Manager
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Manufacturing Technician
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Project Manager - R&D
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Design Assurance Engineer
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Quality Manager
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R&D Manager
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Principal Engineer
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Reliability Engineering Consultant - Rem
Republic of Ireland
Republic of Ireland
R&D Engineer
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Reg Affairs Specialist
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Senior R&D Engineer
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Process Support Specialist
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Product Development Engineer II
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Principal Software Engineer
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Manufacturing Technician
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Senior R&D Manager
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Procurement Associate
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Quality Control Technician
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Senior Project Engineer
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Production Operator
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Principal R&D Engineer
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Senior Microbiologist
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Principal Device Engineer
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Quality Engineer
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Biostatistician
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R&D Engineer
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Senior Design Assurance Engineer
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Responsible Person (RP)
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Senior R&D Engineer
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Quality Engineer
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Senior R&D Engineer
Clare
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Maintenance Reliability Engineer
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Principal Engineer
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Head of R&D
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Senior R&D Engineer
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Quality Technician
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Project Engineer
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Principal Process Equipment Engineer
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Manufacturing Engineer
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VP of Operations
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Production Operator
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Quality Systems Manager
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Senior Maintenance Technician
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Senior R&D Engineer
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Senior Design Engineer
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Maintenance Technician
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Quality Manager - NPI
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R&D Director
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Quality Director
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Quality Assurance Engineer
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Senior Associate QC
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CAPA Specialist
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Cavan
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Engineering Projects Lead
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Manufacturing Technician
Clare
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Manufacturing Engineer
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Lead Manufacturing Technician
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Staff R&D Engineer
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R&D Manager
Galway
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Product Development Engineer
Dublin
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R&D Technician II
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Quality Manager - Medical Devices
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Republic of Ireland
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Principal Engineer
Galway
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Injection Moulding Engineer
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Senior QC Microbiology
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Biomedical Engineer
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Dublin
Product Development Engineer
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Product Development Engineer
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Program Manager
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NPI Process Engineer
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Senior Design Engineer
Dublin
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Validation Engineer
Athlone
Athlone
Senior Manufacting Engineer
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Republic of Ireland
Quality Engineer
Athlone
Athlone
Senior R&D Engineer
Galway
Galway
Cleaning Validation Engineer
Carlow
Carlow
Quality Specialist
Clare
Clare
CTO
Dublin
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Galway
Galway
Senior Quality Engineer
Leitrim
Leitrim
Quality Specialist
Clare
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Graduate Manufacturing Technician
Kilkenny
Kilkenny
Design Assurance Engineer
Galway
Galway
Injection Moulding Engineer
Leitrim
Leitrim
Electronic Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Senior Quality Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
R&D Director
Galway
Galway
Quality Control Technician
Carlow
Carlow
Lead Maintenance Reliability Engineer
Westmeath
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Senior Electronic Engineer
Dublin
Dublin
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
R&D Manager
Galway
Galway
R&D Manager
Connaught
Connaught
Senior Electronics Engineer
Dublin
Dublin
Senior R&D Engineer
Clare
Clare
E&I Turnover Engineer
Carlow
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Senior Mechanical Engineer
Dublin
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CTO
Galway
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R&D Technician
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QA Specialist (Shift days)
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Dublin
Quality Engineer
Galway
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Senior Quality Engineer
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Manufacturing Technician
Clare
Clare
Senior R&D Engineer
Dublin
Dublin
R&D Manager
Athlone
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Quality Specialist
Clare
Clare
Project Manager - R&D
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Carlow
Carlow
Quality Engineer
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Galway
Project Manager - R&D
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Galway
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Carlow
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Dublin
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Galway
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Dublin
Facilities Engineer
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Carlow
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Dublin
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Quality Engineer
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Carlow
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Galway
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Limerick
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NPI Process Engineer
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Westmeath
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DeltaV Lead Automation Engineer
Tipperary
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Process Engineer
Galway
Galway
Mechanical Technician
Carlow
Carlow
R&D Manager
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Production Operator
Meath
Meath
QC Bioanalytical Analyst
Dublin North
Dublin North
Senior Operations Engineer
Galway
Galway
Production Operator
Dublin
Dublin
R&D Engineer
Dublin
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Product Development Engineer
Galway
Galway
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Project Manager
Kildare
Kildare
Maintenance Technician
Kilkenny
Kilkenny
Utilities Engineer
Dublin
Dublin
Senior R&D Engineer
Clare
Clare
Project Manager - R&D
Galway
Galway
R&D Engineer
Galway
Galway
Injection Molding Engineer
North Leinster
North Leinster
Process Engineer
Cork
Cork
Electronic Engineer
Dublin
Dublin
Quality Engineer
Galway
Galway
Production Manager
Dublin
Dublin
Quality Specialist
Tipperary
Tipperary
MS&T Associate Director
Dublin
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R&D Engineer
Galway
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Senior Manufacturing Manager
Dublin
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Lead Manufacturing Technician
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R&D Manager
Galway
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Cork
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Facilities Engineer
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Account Manager UK and Ireland
Republic of Ireland
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Senior R&D Engineer
Dublin
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Maintenance Technician
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R&D Engineer
Galway
Galway
Senior Quality Engineer
Dublin
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QA Engineer
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Leitrim
Principal Engineer
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R&D Manager
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Lead Project Engineer
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Program Manager
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Program Manager
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R&D Engineer
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Search Results for Regulatory Affairs Manager
Job Title. | Location | Salary | Actions |
Regulatory Affairs MaangerRegulatory Affairs Manager Our client a fast-growing medical device company based in the West of Ireland, dedicated to transforming outcomes for patients are seeking a highly motivated Regulatory Affairs Manager to lead and oversee all regulatory compliance activities. This critical leadership role will define and execute regulatory strategies in support of both new product development and post-market activities. Role/Responsibilities Lead the regulatory strategy for new product introductions and support existing products through their full lifecycle. Mana...Location: Galway, |
Galway | 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 | |
Quality Manager - NPIRole: Quality Manager - NPI Based in Dun Laoghaire – on site role Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution, excellent opportunity to expand your career in exciting Medical Device company growing from strength to strength. Company: My client have deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. Job Purpose: To provide support for ISO9000/ISO13485 Quality System. Responsible for ensuring adherence to al...Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South, |
EU | Not Disclosed |
Regulatory Affairs Manager Career Profile
Regulatory Affairs Manager
This role is normally suited to someone with a minimum of 5 years in a Regulatory setting, ideally more. Management, departmental budgeting, training are some of the keys tasks involved on the non-technical side of the role.
Key Responsibilities
- Coordinating, compiling and submitting Marketing Authorisation variations for existing approvals
- Composing and reviewing Pre-IND information packages and NDA packages for registration of prescription products in the US through the FDA
- Liaise with partner companies as the primary Regulatory Affairs contact for the company to achieve product registration in all new worldwide regions within projected timeframes
- Regulatory Affairs European project team leader for all new projects
- Interpreting EU and US regulatory guidelines and procedures and ensuring the regulatory compliance of the company in all new regions Establish and analyse department budget
- Identify and recommend areas for cost savings from and Regulatory and compliance perspective
- Provide Regulatory advice and feedback for all internal company departments and external partners
- Maintain and apply a high level of awareness and understanding of the impact of existing and future planned regulations
Medical Device Packaging Engineer Sales and Marketing Product Development Engineer Quality Assurance Validation Engineer PhD Pharmaceutical Chemistry Biotechnology Limerick Manufacturing Executive Mayo Cork Scientist Cork City Microbiology Academic Life Science Laboratory Scientist Biopharmaceutical Diagnostics Quality Control Engineering Project Manager Supply Chain Supply Chain Academic Quality Engineering Scientific Allied Healthcare IT Connected Health Sales and Marketing Dublin Medical Affairs Pharma Sales Clinical Research
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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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