Clinical Evidence Planning and Evaluations Manager

🔥 27 minutes ago

🇨🇦 Canada – Remote

💵 $93k - $132.5k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 0%

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Siemens Healthineers

WebsiteLinkedInAll Job Openings

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

• Develop and execute clinical evidence strategies for Software as a Medical Device (SaMD), digital health, and AI-enabled solutions across the product lifecycle • Author and maintain Clinical Evaluation Plans and Reports (CEP/CER) and Post-Market Clinical Follow-up Plans and Reports (PMCFP/PMCFR) to support global regulatory compliance and market access • Partner with Regulatory Affairs, Quality, Product Management, Risk Management, Engineering, and Medical Affairs to define and address clinical evidence requirements • Lead evidence generation activities, including literature evaluations, clinical performance assessments, real-world evidence analyses, and post-market surveillance initiatives • Support clinical benefit-risk assessments, intended use validation, and product claims substantiation • Monitor post-market clinical data and emerging evidence to identify gaps, risks, and opportunities for continuous improvement • Support clinical evidence strategy and clinical evaluations for Varian devices in radiation oncology and interventional oncology • Partner cross-functionally across product development, risk management, post-market surveillance, and customer-facing content

🎯 Requirements

• Working knowledge of Clinical Evaluation and Post-Market Clinical Follow-up requirements under the European Union Medical Device Regulation (EU MDR), particularly for software-based medical devices • Master's degree or higher in Biomedical Engineering, Medical Physics, Computer Science, Health Sciences, Public Health, Biostatistics, or a related field; equivalent experience will be considered • 3+ years of experience in clinical evaluation, clinical evidence generation, medical devices, SaMD, digital health, or a related field • Experience evaluating clinical data, scientific literature, and real-world evidence to support regulatory and business objectives • Experience with Software as a Medical Device (SaMD), digital health technologies, AI-enabled medical devices, or healthcare software solutions • Understanding of clinical evidence generation, clinical performance evaluation, and post-market surveillance principles • Strong scientific writing, critical analysis, and communication skills • Familiarity with AI/ML-enabled medical technologies, clinical performance validation, and software lifecycle processes is preferred • Ability to work independently in a remote setting

🏖️ Benefits

• Flexible benefits plan • Defined Contribution Pension Plan • Registered Retirement Savings Plan matching contributions • Competitive paid time off program including vacation, company holidays, sick leave, and parental leave