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Our client is seeking an experienced R&D Compliance Specialist to serve as the primary Quality and Compliance expert within a multidisciplinary R&D organization. This role will ensure that product lifecycle activities, engineering changes, and compliance processes meet the highest quality and regulatory standards while supporting innovative healthcare technologies.
Our client is seeking a senior Regulatory Affairs professional to drive EU and global regulatory strategies across complex development and lifecycle programmes. This role combines strategic leadership, health authority interaction, submission oversight, and cross-functional project leadership in an international environment.
Notre client recherche un(e) Spécialiste Qualification pour renforcer son équipe Assurance Qualité dans le cadre de ses activités de production et d'amélioration continue. Vous contribuerez à garantir la conformité des équipements et systèmes aux exigences qualité et réglementaires en vigueur.
The Director BLA Program Management will be the in-house operational leader responsible for integrating, driving and de-risking the BLA planning. The primary accountability will be to build and manage the submission's critical path across Regulatory, CMC/Technical Operations, Quality,Clinical, Safety, Biometrics, Medical Writing, Regulatory Operations, and external vendors by integrating the respective functional plans.
This hybrid role combines translation quality assurance and revision (50%) with project coordination activities (50%). The successful candidate will be responsible for ensuring the quality and consistency of Spanish-language content while coordinating multilingual workflows, stakeholders, and external language service providers.
Als Regulatory Affairs Specialist übernehmen Sie eine zentrale Rolle an der Schnittstelle zwischen Produktsicherheit, Compliance und internationalen Behörden. Sie koordinieren regulatorische Anfragen, sorgen für die Einhaltung gesetzlicher Vorgaben und unterstützen interne wie externe Stakeholder bei sämtlichen Fragestellungen rund um Produktkonformität und Nachhaltigkeit.
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