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Clinical Evidence Planning and Evaluations Manager
Siemens Healthineers. Develop and execute clinical evidence strategies for Software as a Medical Device (SaMD), digital health, and AI-enabled solutions across the product lifecycle .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing clinical evidence strategies for Software as a Medical Device (SaMD) and digital health solutions, with a strong focus on clinical evaluation, regulatory compliance, and evidence generation activities. Proficient in scientific writing and critical analysis to support product claims and benefit-risk assessments.
Highest-signal resume keywords
Clinical EvaluationPost-Market Clinical Follow-UpSoftware as a Medical Device (SaMD)Regulatory ComplianceClinical Evidence Generation
ATS Keywords
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Hard Skills
Clinical Evaluation PlansClinical Performance EvaluationReal-World Evidence AnalysisLiterature EvaluationBenefit-Risk AssessmentData MonitoringAI-Enabled Medical DevicesDigital Health TechnologiesPost-Market SurveillanceScientific Writing
Soft Skills
Critical AnalysisCommunication SkillsIndependent Work
Certifications & Qualifications
Master's Degree in Biomedical EngineeringMaster's Degree in Medical PhysicsMaster's Degree in Computer ScienceMaster's Degree in Health SciencesMaster's Degree in Public HealthMaster's Degree in Biostatistics
Industry Keywords
European Union Medical Device Regulation (EU MDR)Healthcare Software SolutionsClinical Performance ValidationSoftware Lifecycle ProcessesRadiation OncologyInterventional Oncology
About the role
Key responsibilities & impact- 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)
- 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 global regulatory compliance and market access for Varian devices in radiation oncology and interventional oncology
Requirements
What you’ll need- 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
Comp & perks- Flexible benefits plan
- Defined Contribution Pension Plan
- Registered Retirement Savings Plan matching contributions
- Competitive paid time off program
- Vacation
- Company holidays
- Sick leave
- Parental leave