Clinical Evidence Planning and Evaluations Manager

About the role

Join Siemens Healthineers to lead clinical evidence strategy for software‑based medical devices, including SaMD, digital health and AI‑enabled solutions. You will partner across product development, risk management, post‑market surveillance and customer‑facing teams to ensure regulatory compliance and market access.

Key responsibilities

• Develop and execute clinical evidence strategies across the product lifecycle for SaMD, digital health and AI‑enabled solutions.
• Author and maintain Clinical Evaluation Plans/Reports (CEP/CER) and Post‑Market Clinical Follow‑up Plans/Reports (PMCFP/PMCFR) to support global regulatory compliance.
• Collaborate with Regulatory Affairs, Quality, Product Management, Risk Management, Engineering and Medical Affairs to define clinical evidence requirements.
• Lead evidence generation activities such as literature reviews, clinical performance assessments, real‑world evidence analyses and post‑market surveillance initiatives.
• Support benefit‑risk assessments, intended‑use validation and product‑claims substantiation.
• Monitor post‑market clinical data and emerging evidence to identify gaps, risks and improvement opportunities.

Required profile

• Experience with SaMD, digital health technologies or AI‑enabled medical devices.
• Understanding of clinical evidence generation, performance evaluation and post‑market surveillance principles.
• Strong scientific writing, critical analysis and communication skills.
• Ability to work collaboratively in a cross‑functional environment and independently in a remote setting.
• Working knowledge of Clinical Evaluation and Post‑Market Clinical Follow‑up requirements under EU MDR for software‑based devices.
• Master’s degree or higher in a relevant field (e.g., Biomedical Engineering, Medical Physics, Computer Science, Health Sciences, Public Health, Biostatistics) or equivalent experience.
• At least 3 years of experience in clinical evaluation, evidence generation or related medical‑device roles.
• Familiarity with AI/ML‑enabled medical technologies, clinical performance validation and software lifecycle processes is preferred.

Required skills

• Clinical Evaluation
• Post‑Market Clinical Follow‑up
• EU MDR compliance
• Scientific writing
• Literature review and real‑world evidence analysis

What we offer

• Health and wellness benefits including a flexible benefits plan.
• Defined contribution pension plan with RRSP matching contributions.
• Competitive paid time off program covering vacation, company holidays, sick leave and parental leave.