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Device Project Manager

1 month ago

Cambridge, Cambridgeshire, United Kingdom Novartis Full time
Device Project Lead

Sandoz is undergoing a transformative period as a global leader in sustainable Generic and Biosimilar medicines. As an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for its associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for professional and personal growth.

Your Key Responsibilities:
  • Project leadership, including planning, coordination, specifications, risk management, documentation, design transfer, and more.
  • Development oversight, encompassing market research, user research, concept generation, development, and analysis, as well as detail design, ergonomics, and usability.
  • Creation and management of Design History Files and associated documentation for selected combination products, following the annual plan and objectives, and relevant standards such as ISO13485 and 21 CFR Part 820.30.
  • Leading, representing, and managing cross-functional device project teams.
  • Management of activities following project strategies, budget, timelines, regulatory, quality, and professional standards.
  • Enabling operational excellence in compliance with current and anticipated professional trends.
  • Performing activities in compliance with Good Manufacturing Practice.
  • Ensuring inspection readiness.