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Senior Device Project Lead

Full-Time England, United Kingdom
Health & Biotech
Health & Biotech
14 May 2024
  • 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
  • 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.
  • Strong Collaboration skills across boundaries.
  • Cross-cultural experience.
  • Functional breadth
  • Project management
  • Regulatory Submissions.


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