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 .

Posted 9/17/2026full-timeRemote • CanadaMid-LevelSenior💰 CA$93,000 - CA$132,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing clinical evidence strategies for Software as a Medical Device (SaMD) and digital health solutions, with a strong focus on regulatory compliance and evidence generation. Proficient in clinical evaluation, post-market surveillance, and cross-functional collaboration to support product lifecycle management.

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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Applicant Tracking System Keywords

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Hard Skills

Clinical Evaluation PlansClinical Performance AssessmentsReal-World Evidence AnalysisScientific Literature EvaluationCritical AnalysisData MonitoringBenefit-Risk AssessmentIntended Use ValidationProduct Claims SubstantiationPost-Market Surveillance

Soft Skills

Strong Scientific WritingCommunication SkillsIndependent Work

Tools & Technologies

AI-Enabled Medical DevicesDigital Health TechnologiesHealthcare Software Solutions

Industry Keywords

European Union Medical Device Regulation (EU MDR)Biomedical EngineeringMedical PhysicsHealth SciencesPublic HealthBiostatistics

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) 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

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 including vacation, company holidays, sick leave, and parental leave