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Clinical Evidence Planning and Evaluations Manager
Posted 2 weeks ago
About the role
- Clinical evidence manager guiding regulatory evaluations for Siemens Healthineers’ radiation and interventional oncology devices. Developing SaMD strategies, clinical reports, and post-market evidence for global compliance.
Responsibilities
- 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
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