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Quality Engineer
Athlone
Athlone
Quality Engineer
Galway
Galway
Project Engineer
Limerick
Limerick
R&D Manager
Galway
Galway
Reliability Engineer
Tipperary
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Senior Quality Engineer
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Senior Electronic Engineer
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Principal Engineer
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Quality Specialist
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Process Support Specialist
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R&D Manager
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Senior Associate QC
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Project Manager - R&D
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R&D Director
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R&D Technician II
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Design Assurance Engineer
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Technical Transfer Specialist - Remote
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Utilities Engineer
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R&D Manager
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Production Operator
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Quality Engineer
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Microbiologist
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Electronic Engineer
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Senior Electrical Engineer
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Senior R&D Engineer
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Facilities Engineer
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Process Engineer
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Senior Manufacting Engineer
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Quality Specialist
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Embedded Software Engineer
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Quality Specialist
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Senior R&D Engineer
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Senior R&D Engineer
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Program Manager
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Electronic Engineer
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Principal R&D Engineer
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Product Development Engineer II
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Senior R&D Engineer
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Senior Quality Engineer
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Operations Engineer
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Director of Quality Engineering
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R&D Manager
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Senior Recruitment Consultant
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E&I Turnover Engineer
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Quality Engineer
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Product Development Manager
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Program Manager
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Project Manager
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Principal Software Engineer
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Athlone
MS&T Associate Director
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R&D Engineer
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Senior Quality Engineer
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QA Manager
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Senior Design Engineer
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Staff Systems Engineer
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Manufacturing Technician
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Senior R&D Engineer
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Project Scheduler
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VP of Operations
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Accreditation Manager
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Regulatory Affairs Maanger
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Product Development Engineer
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Mechanical Engineer
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Tipperary
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Search Results for Regulatory Affairs Officer
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 | |
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 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 |
Regulatory Affairs Officer Career Profile
Regulatory Affairs Officer
The Regulatory Affairs (RA) department is tasked with ensuring that the company complies with all of the local and international regulations and laws pertaining to their business. The Regulatory Affairs Officer works with international, state and local regulatory agencies, such as the Irish Medicines Board (IMB), the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) on specific issues affecting their business. The Regulatory Affairs Officer advises the company on the current regulatory aspects and climate that would affect proposed activities. The RA Officer has many interactions within the medical affairs dept. including medical information, pharmacovigilance and clinical trials.
Key responsibilities of the Regulatory Affairs Officer
- Maintenance of Irish and overseas licenses including preparation of variation and renewal applications as appropriate.
- Preparation and submission of Marketing Authorisation applications to EU regulatory authorities.
- Preparation of dossiers to obtain CE marking for medical devices.
- Ensuring Labelling complies with appropriate legislation.
- Ensure approved regulatory requirements are enforced in-house.
- Participate in the development of electronic submission of dossiers.
- Provide support to R&D projects; including new product introductions, changes to existing products and processes.
- Liaise with suppliers, clients, development partners and regulatory bodies.
- Ensure guidelines and knowledge of legislation is current and be able to advise of future developments and changes.
- Monitor the process of regulatory submissions, responding to queries and ensuring that registration approvals are granted without undue delay.
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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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