
Regulatory Affairs Leader
1 week ago
Our company is seeking an experienced Regulatory Affairs Director (Europe) to lead our regulatory strategy and execution across European markets. This key leadership role is responsible for guiding products through clinical development, marketing authorization, and lifecycle management, while serving as the primary regulatory interface with EMA and national competent authorities.
This role involves leading the development and execution of European regulatory strategy in alignment with global objectives. It also requires overseeing preparation, submission, and maintenance of regulatory dossiers to ensure timely approvals.
The successful candidate will serve as the primary liaison with EMA and national health authorities, managing communications, negotiations, and regulatory interactions.
They will provide regulatory leadership and guidance during product development, registration, and post-market activities. Ensuring compliance with EU regulatory requirements, including applicable directives and guidelines, is also a key responsibility.
This position requires strong experience working in dynamic, cross-functional, and international environments.
It also demands exceptional communication, negotiation, and collaboration skills, with the ability to influence senior stakeholders.
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Pediatric Regulatory Affairs Leader
2 weeks ago
Dublin, Dublin City, Ireland beBeeRegulatory Full time €145,000 - €185,000We are creating a healthier world by developing therapies that improve lives and ensure access globally.Our team plays a critical role in discovering and developing life-changing scientific innovations. Every member is our greatest asset as we work to achieve our bold ambitions, seeking passionate individuals ready to make a direct impact.We believe every...
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Regulatory Affairs Specialist
1 week ago
Dublin, Dublin City, Ireland beBeeRegulatory Full time €120,000 - €168,000Global Regulatory Affairs LeaderThis is a senior role within our organization that oversees the development and execution of global regulatory strategies. The Global Regulatory Affairs Leader will be responsible for creating high-quality regulatory strategies, managing health authority interactions, and ensuring strategy execution.The ideal candidate will...
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Regulatory Affairs Expert
1 week ago
Dublin, Dublin City, Ireland beBeeRegulatoryAffairs Full time €75,000 - €95,000Job Title: Regulatory Affairs ExpertWe are seeking a highly skilled Regulatory Affairs Expert to join our team. As a key member of our regulatory affairs group, you will play a critical role in ensuring that our medical devices comply with all relevant regulations and standards.About the RoleThis is an exciting opportunity to work with a leading medical...
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Regulatory Affairs Specialist
2 weeks ago
Dublin, Dublin City, Ireland beBeeRegulatory Full time €80,000 - €100,000Regulatory Affairs ProfessionalThe ideal candidate will have a strong background in regulatory affairs, specifically in medical devices.Main Responsibilities:Develop and implement regulatory strategies to ensure compliance with European and US regulations.Support the creation and maintenance of product design and technical documentation in accordance with...
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Regulatory Affairs Professional
1 week ago
Dublin, Dublin City, Ireland beBeeRegulatoryAffairs Full time €70,000 - €95,000Job Title: Regulatory Affairs SpecialistDescription:The Senior Specialist, Regulatory Affairs position is responsible for overseeing post-market activities for medical devices and supporting departmental regulatory processes and procedures. This role also involves mentoring team members to ensure seamless execution of tasks.Key Responsibilities:Develop and...
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Regulatory Affairs Professional
2 weeks ago
Dublin, Dublin City, Ireland beBeeRegulatory Full time €80,000 - €100,000Regulatory Affairs Professional Role OverviewThis is a key role in the development of cutting-edge structural heart devices, working closely with cross-functional teams to ensure compliance with internal and external regulatory requirements.Key Responsibilities:Clinical:Coordinate and support global clinical trial execution, including site activation,...
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Global Regulatory Affairs Strategist
7 days ago
Dublin, Dublin City, Ireland beBeeRegulatory Full time €100,000 - €140,000Global Regulatory Affairs StrategistAre you a seasoned professional in regulatory affairs looking to take on a leadership role? We are seeking an Associate Director Regulatory Affairs to join our team and contribute to the development of global regulatory strategies for assigned products.
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Regulatory Affairs Professional
2 weeks ago
Dublin, Dublin City, Ireland beBeeRegulatoryAffairs Full time €90,000 - €121,000Regulatory Affairs Specialist Job DescriptionThis is a key role in our organization, responsible for post-market activities for Administration and Safety System medical devices. We are seeking an experienced Regulatory Affairs Specialist to join our team.Job Summary:The successful candidate will be responsible for performing post-market surveillance...
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Director of Regulatory Affairs
1 week ago
Dublin, Dublin City, Ireland Morgan Prestwich - Life Science & Healthcare Executive Search Full timeOverviewOur client is a leading Rare Disease biopharmaceutical company committed to advancing innovative treatments to improve patient outcomes. Their mission is to transform care by delivering cutting-edge therapies while fostering strong scientific engagement with healthcare professionals and researchers.Our client is seeking a highly experienced Director...
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Director, Regulatory Affairs CMC
3 weeks ago
Dublin, Dublin City, Ireland Cytokinetics Full timeOverviewJoin to apply for the Director, Regulatory Affairs CMC role at Cytokinetics.Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac...