Assists in the planning and execution of assigned projects while adhering to budget, scope, and schedule requirements.
Helps ensure consistent practices throughout all phases of the project lifecycle.
Prepares technical reports, summaries, protocols, and quantitative analyses.
Executes high quality, integrated cross-functional plans for projects.
Applies best practices in the development, initiation, planning, execution, control and closing of projects.
Interacts with research and development, marketing, manufacturing, and regulatory departments.
A seasoned, experienced professional with a full understanding of area of specialisation; resolves a wide range of issues in creative ways.
Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
Networks with senior internal and external personnel in own area of expertise.
Mentor and SME to all other Device Project Leads in SDDC
Qualifications
Proven track record (10+ years) in development of medical devices and /or combination products within a pharmaceutical, medical devices, and/or combination products setting with significant cross-functional team management responsibilities.
Extensive technical knowledge of medical device technology and drug-device combination products.
Strong leadership skills and proven track record in leading a group of device development professionals.
Experience of working within the ISO13485 medical devices quality framework and in-depth knowledge of GMP, EU, and FDA regulatory requirements.
Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt.
