09 Oct
|
Novartis
|
Hyderabad
09 Oct
Novartis
Hyderabad
Band
Level 5
Job Description Summary
LI-Hybrid
Location: Hyderabad, India
Relocation Support: This role is based in Hyderabad, India. Novartis is unable to offer relocation support: please only apply if accessible.
What happens when cutting-edge medicines meet equally cutting-edge device technology? Patients receive treatments that can transform lives. As Technical Steward – Devices, you will be at the center of that intersection, providing technical leadership for medical devices and drug-device combination products throughout their lifecycle. From late-stage development and technology transfer to commercialization, lifecycle management, and product retirement, you will ensure that device technologies are fit for purpose, compliant, and capable of supporting reliable product delivery. Working with global suppliers, cross-functional partners, and regulatory stakeholders, you will serve as a trusted device expert, lead strategic product activities, and manage a team of specialists dedicated to advancing some of Novartis’ most important therapies.
Job Description
Key Responsibilities
• Serve as the device expert for high-priority brands, overseeing auto-injectors and other drug-delivery systems throughout their life-cycle.
• Assess how device technologies operate with drug products, identifying compatibility, performance, quality, and patient-use risks.
• Review supplier documentation and technical data to confirm devices perform as intended and meet health authority requirements.
• Lead technical activities from late-stage development and technology transfer through scale-up, commercialization, life-cycle maintenance, and product retirement.
• Prepare and maintain device documentation, including design history, risk management, human factors, and post-market surveillance files.
• Respond to health authority questions and provide technical input for regulatory submissions involving devices and combination products.
• Investigate device-related quality issues, evalu
📌 Technical Steward (Hyderabad)
🏢 Novartis
📍 Hyderabad