Device Project Lead

2 weeks ago


Cambridge, United Kingdom Novartis Full time
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now 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 us, the Sandoz 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.

Join us as a Founder of our ‘new’ Sandoz

Your Key Responsibilities:
Your responsibilities include, but 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)"
•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;
•Lead, represent, and manage cross-functional device project teams;
•Management of activities following project strategies, budget, timelines, regulatory, quality, and professional standards;
•Enabling operational excellence in compliance with the current and anticipated professional trends;
•Performing activities in compliance with Good Manufacturing Practice
•Ensuring inspection readiness.
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