
Regulatory Affairs Expert
2 days ago
We are seeking a highly skilled Regulatory Affairs Expert to join our organization.
Key Responsibilities- Develop and implement regulatory strategies to obtain and maintain regulatory approval for medical devices in target markets.
- Lead design reviews in compliance with internal procedures and EU and FDA requirements, including maintaining design history files and managing the filing, storage, and retrieval of quality records.
- Excellent understanding of global medical device regulations, particularly in accordance with FDA guidance and the Medical Device Directive (MDD 93/42 EEC).
- Proven ability to develop and implement effective regulatory strategies, ensuring compliance with company and regulatory requirements.
The ideal candidate will enjoy a comprehensive benefits package, including a competitive salary, excellent benefits, and opportunities for career growth and development.
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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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Senior Regulatory Affairs Expert
4 days ago
Galway, Galway, Ireland beBeeRegulatory Full time €70,000 - €95,000Regulatory Affairs SpecialistWe 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...
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Graduate Regulatory Affairs Specialist
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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 Professional
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Galway, Galway, Ireland beBeeRegulatory Full time €85,000 - €105,000Our ideal candidate will be a strategic leader with expertise in regulatory affairs, overseeing the development and implementation of regulatory strategies to ensure compliance with all applicable laws and regulations.Job DescriptionAs a Regulatory Affairs Manager, you will play a critical role in defining and executing regulatory strategies that support...
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Senior Regulatory Affairs Professional
2 days ago
Galway, Galway, Ireland beBeeRegulatory Full time €100,000 - €130,000We are seeking a highly skilled Senior Regulatory Affairs Professional to lead our regulatory affairs program in Galway, Ireland.Job DescriptionThe successful candidate will provide independent regulatory guidance to product development teams on International pre-marketing applications, and any related submissions to support optimal timelines for...
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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,...
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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
2 days 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 Specialist
3 hours ago
Galway, Galway, Ireland beBeeRegulatoryAffairs Full time €60,000 - €90,000Seeking a Senior Regulatory Affairs Professional with expertise in developing regulatory strategies and obtaining approval for medical device commercialization.The ideal candidate will possess a deep understanding of global medical device regulations, including FDA guidance and MDD 93/42/EEC. They will collaborate with regulatory affairs management to...