Senior Regulatory Affairs Expert
1 day ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory department, you will play a critical role in ensuring that our medical devices comply with all relevant regulations and guidelines.
The successful candidate will have a strong understanding of global medical device regulations, including the FDA's Quality System Regulation (21 CFR 820) and the Medical Device Directive (93/42/EEC). They will be responsible for developing and implementing regulatory strategies, preparing submissions to regulatory authorities, and communicating with regulatory officials to ensure timely product approvals.
Key Responsibilities:- Maintain an excellent understanding of global medical device regulations
- Develop global regulatory strategies for the company
- Prepare regulatory submissions to regulatory authorities
- Communicate directly with regulatory officials to ensure timely product approvals
- Minimum 5 years' experience in Regulatory Affairs or a related field
- Primary and/or postgraduate degree in a relevant technical field
- Working knowledge of FDA requirements and applicable harmonized standards
- Previous experience with submissions to US FDA is a distinct advantage
If you are a motivated and detail-oriented professional with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.
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Regulatory Affairs Lead
2 weeks ago
Galway, Galway, Ireland beBeeRegulatory Full time €90,000 - €100,000Regulatory Affairs Lead">">We are seeking a skilled Regulatory Affairs professional to lead our regulatory strategy in Galway, Ireland.">As Senior Regulatory Affairs Program Lead, you will provide expert guidance on International pre-marketing applications and support optimal timelines for new/modified product launches.">Key responsibilities include...
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Graduate Regulatory Affairs Specialist
3 weeks ago
Galway, Galway, Ireland Veryan Medical Full timeJoin to apply for the Graduate Regulatory Affairs Specialist role at Veryan MedicalJoin to apply for the Graduate Regulatory Affairs Specialist role at Veryan MedicalGet AI-powered advice on this job and more exclusive features.Direct message the job poster from Veryan MedicalHR Coordinator, Veryan Medical | Assoc CIPD | MSc HRMGraduate Opportunity:...
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Regulatory Affairs Lead
2 weeks ago
Galway, Galway, Ireland beBeeRegulatory Full time €90,000 - €120,000Senior Regulatory Affairs ProfessionalWe are seeking a Senior Regulatory Affairs Specialist to lead our regulatory activities including product certification and compliance.The successful candidate will be responsible for managing the regulatory and vigilance process, preparing regulatory submissions for required markets, and maintaining technical files for...
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Senior Regulatory Affairs Program Lead
1 week ago
Galway, Galway, Ireland Johnson & Johnson Full timeAt Johnson & Johnson, we believe health is everything.Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across...
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Senior Regulatory Affairs Program Lead
21 minutes ago
Galway, Galway, Ireland Johnson & Johnson Full timeAt Johnson & Johnson, we believe health is everything.Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across...
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Senior Regulatory Affairs Program Lead
2 weeks ago
Galway, Galway, Ireland Johnson & Johnson Full timeAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across...
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Senior Regulatory Expert
2 weeks ago
Galway, Galway, Ireland beBeeRegulatory Full time €114,390 - €128,550Job Function:Regulatory AffairsSub Function:Regulatory Product Submissions and RegistrationWe are seeking a highly skilled professional to lead our Regulatory Affairs Program in Galway, Ireland.The successful candidate will provide independent regulatory guidance to product development teams on International pre-marketing applications, and any related...
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Senior Regulatory Affairs Professional
2 weeks ago
Galway, Galway, Ireland beBeeRegulatory Full time €80,000 - €110,000Job Role: Senior Regulatory Affairs SpecialistJob DescriptionThe ideal candidate will play a key role in the implementation of post-market activities, ensuring compliance with relevant Quality System procedures and Work Instructions.This position involves coordinating the approval of Vigilance/MDR reporting as defined in each territory, supporting and...
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Principal Regulatory Affairs Specialist
2 weeks ago
Galway, Galway, Ireland Boston Scientific Full timeDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training,...
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Principal Regulatory Affairs Specialist
1 week ago
Galway, Galway, Ireland Boston Scientific Full timeDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges.With access to the latest tools, information and training,...
