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Reposted 3 Days AgoSaved
In-Office
North Hill, Dublin, IRL
Senior level
Senior level
Healthtech • Biotech • Pharmaceutical
Manage and publish regulatory dossiers for product submissions, ensuring compliance and quality control while mentoring junior staff. Act as a subject matter expert for publishing activities.
Top Skills: Adobe Acrobat ProfessionalDocument Management SystemsEctd Publishing SoftwareMS Office
Reposted 4 Days AgoSaved
In-Office
Jamestown, Dublin, IRL
Junior
Junior
Healthtech • Biotech • Pharmaceutical
The QC Analyst will conduct testing of materials and products, drive KPI achievement, update documentation, troubleshoot methods, engage in projects, and maintain equipment care.
Top Skills: HplcLabxLimsUv Software
Reposted 8 Days AgoSaved
In-Office
North Hill, Dublin, IRL
Senior level
Senior level
Healthtech • Biotech • Pharmaceutical
The Director of Regulatory Compliance will establish and lead the Global Regulatory Affairs Compliance function, ensuring adherence to regulatory processes, managing audits, and evolving the Quality Management System while collaborating with cross-functional teams.
Top Skills: Quality Management Systems (Qms)
Reposted 8 Days AgoSaved
In-Office
North Hill, Dublin, IRL
Senior level
Senior level
Healthtech • Biotech • Pharmaceutical
The Senior Specialist will oversee global regulatory operations, ensuring compliance with EU regulations, managing data governance, and leading process improvements within regulatory initiatives.
Top Skills: EctdIdmpExcelMicrosoft WordRegulatory Information Management SystemsSpor
Reposted 8 Days AgoSaved
In-Office
Baldoyle, Dublin, IRL
Senior level
Senior level
Healthtech • Biotech • Pharmaceutical
The Senior Quality Director oversees quality operations, ensuring compliance with regulatory standards and leading quality management initiatives to ensure product quality.
Top Skills: GmpLean ManufacturingQaQcQms
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Reposted 9 Days AgoSaved
In-Office
Jamestown, Dublin, IRL
Junior
Junior
Healthtech • Biotech • Pharmaceutical
The QC Analyst - Micro role involves analyzing raw materials and products, monitoring manufacturing areas, and performing method validations while adhering to GMP standards.
Top Skills: Analytical TestingGmpMicrobiology Laboratory
17 Days AgoSaved
In-Office
North Hill, Dublin, IRL
Mid level
Mid level
Healthtech • Biotech • Pharmaceutical
As the Global Regulatory Business Process Lead, you will optimize regulatory processes, ensure adherence to compliance, and utilize data analytics for continuous improvement. You'll collaborate cross-functionally and lead training initiatives.
Top Skills: Six SigmaVisio
Reposted 19 Days AgoSaved
In-Office
North Hill, Dublin, IRL
Expert/Leader
Expert/Leader
Healthtech • Biotech • Pharmaceutical
Lead regulatory strategy and compliance for medical devices and drug-device combination products globally. Serve as SME on FDA, EU MDR and ISO standards, guide program teams on regulatory plans and submissions (NDA/ANDA/BLA/MAA), mentor the regulatory team, and support SaMD classification and global IT compliance.
Top Skills: 21 Cfr 820AndaBlaEma GuidanceFda GuidanceIso 13485MaaMdr (Eu) 2017/745NdaSamd (Software As A Medical Device)
Reposted 20 Days AgoSaved
In-Office
North Hill, Dublin, IRL
Senior level
Senior level
Healthtech • Biotech • Pharmaceutical
The Senior Manager, Core Labelling Strategy leads regulatory labelling governance for Viatris, ensuring compliance and strategic direction in labelling documentation and processes for pharmaceutical products.
Top Skills: Labelling GuidelinesRegulatory RequirementsScientific/Technical Writing
Reposted 20 Days AgoSaved
In-Office
Baldoyle, Dublin, IRL
Senior level
Senior level
Healthtech • Biotech • Pharmaceutical
The Operational Excellence Lead drives transformational change, champions Lean Six Sigma, mentors teams, and implements sustainable process improvements to enhance quality and efficiency.
Top Skills: DmaicLean Six SigmaMiroVisio
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