1 of 1 Knowledge Transfer Jobs in Royston

Medical Device, including the implementation and oversight of the software development lifecycle (SDLC) and compliance with IEC 62304 and IEC 82304.Combination Products: Knowledge of drug–device or biologic–device combination products, including awareness of regulatory considerations, CCIT (Container Closure Integrity Testing), and stability/compatibility studies, is considered … advantage.Regulatory and technical strategyInterpreting and applying evolving global combination product regulations, providing pragmatic guidance throughout development, technical transfer, commercialisation and post‐market phases.Supporting the preparation of regulatory submissions, technical dossiers and responses to questions from competent authorities and notified bodies.Technology transfer and lifecycle managementLeading and supporting technology transfer ...