Device Project Lead

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic 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 are not limited to:

• Experience with combination products (or device constituent parts thereof) OR standalone medical devices.
• Project leadership (planning, coordination, specifications, risk management, documentation, design transfer)
• Development oversight including detail design; ergonomics and usability (including HF/UE documentation); lead design reviews
• Creation and management of Design History Files and associated documentation for selected combination products per the annual plan and objectives, and relevant standards and guidelines 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 Practices
• Ensuring inspection readiness.

What you’ll bring to the role:

Essential Requirements:

• University degree in a relevant subject (mechanical engineering, product design, physics etc.) or other equivalent degree with 5+ years of experience
• Work experience in medical devices/combination product development
• Knowledge of GMP and international device regulations;
• Knowledge of regulatory/QA requirements for medical devices/combination products
• Ability to communicate and collaborate effectively in a highly international and diverse setting;
• Digital excellence and automation of documentation management.
• Track record of goal-driven behaviour, problem-solving, ability to make pragmatic decisions, and readiness for new challenges
• Fluency in English

You’ll receive:

Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 24 days annual leave, Flexible working arrangements, Employee recognition scheme, learning and development opportunities.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

The future is ours to shape!

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com)

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