Clinical Evidence Planning & Evaluations Manager

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🔥 0 minutes ago

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Siemens Healthineers

10,000+ employees

🏥 Healthcare

⚕️ Healthcare Insurance

🧬 Biotechnology

💰 $1.5M Grant on 2021-05

Healthcare • Healthcare Insurance • Biotechnology

Siemens Healthineers is a leading MedTech company focused on pioneering breakthroughs in healthcare. They offer a comprehensive portfolio that addresses the entire care continuum for serious diseases, including medical imaging, laboratory diagnostics, point-of-care testing, and digital health solutions. With a commitment to innovation, sustainability, and improving patient access to care, Siemens Healthineers collaborates with healthcare professionals and organizations globally to advance medical technology and enhance patient outcomes.

📋 Description

• Create and drive clinical evidence strategies for Varian’s devices • Develop Clinical Evaluation Plans and Reports and Post-Market Clinical Evaluation Plans and Reports (CEP/CER and PMCFP/PMCFR) • Provide clinical input to cross-functional teams on clinical development, risk management, product management, and post-market surveillance • Execute Post-Market Clinical Follow-Up activities, including customer surveys, annual literature searches, and clinical studies • Review promotional materials and claims supporting customer-facing content

🎯 Requirements

• Familiarity with the design and manufacture of medical devices, especially devices used in radiation oncology • Exemplary technical writing and verbal communication skills • Understanding of Clinical Evaluation and Post-Market Clinical Follow-Up requirements for Class I–III medical devices under the European Union Medical Device Regulation (EU MDR) • Master’s or PhD in Medical Physics, Biophysics, Biomedical Engineering, or another relevant degree program • 3–5 years’ experience with clinical evaluations, medical physics, or a related field • Ability to work with controlled technology in accordance with US export control law

🏖️ Benefits

• Flexible and dynamic work environment • Resources and flexibility for professional and personal growth • Medical insurance • Dental insurance • Vision insurance • 401(k) retirement plan • Life insurance • Long-term and short-term disability insurance • Paid parking/public transportation • Paid time off • Paid sick and safe time

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