Device Project Manager

5 days ago


Cambridge, Cambridgeshire, United Kingdom Novartis Full time

Sandoz is undergoing a transformative period as a global leader and pioneering provider of 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 us all, both professionally and personally.

Your Key Responsibilities:

Your responsibilities include, but are not limited to:

  • Project Leadership: Planning, coordination, specifications, risk management, documentation, design transfer, etc.
  • Development Oversight: Market research; user research; concept generation, development, and analysis; detail design (e.g. including 3D CAD and engineering drawings); ergonomics and usability (including HF/UE documentation); design reviews
  • Design History Files and Documentation: Creation and management of Design History Files and associated documentation for selected combination products following the annual plan and objectives, and relevant standards e.g. ISO13485, 21 CFR Part 820.30, 21 CFR 3.2(e), etc.
  • Project Team Management: Lead, represent, and manage cross-functional device project teams
  • Project Management: Management of activities following project strategies, budget, timelines, regulatory, quality, and professional standards
  • Operational Excellence: Enabling operational excellence in compliance with the current and anticipated professional trends
  • Compliance: Performing activities in compliance with Good Manufacturing Practice
  • Inspection Readiness: Ensuring inspection readiness


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