Senior Device Project Lead
Full-Time
England, United Kingdom
Health & Biotech
Health & Biotech
Description
- 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.
- Strong Collaboration skills across boundaries.
- Cross-cultural experience.
- Functional breadth
- Project management
- Regulatory Submissions.
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