Clinical Evidence Planning and Evaluations Manager

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

As a Clinical Evidence Planning and Evaluations Manager, you will:

• 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.

This position may be a good fit if you:

• Have experience with Software as a Medical Device (SaMD), digital health technologies, AI-enabled medical devices, or healthcare software solutions.
• Understand clinical evidence generation, clinical performance evaluation, and post-market surveillance principles.
• Possess strong scientific writing, critical analysis, and communication skills.
• Thrive in a collaborative, cross-functional environment while working independently in a remote setting.

Required qualifications

• 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.
• Familiarity with AI/ML-enabled medical technologies, clinical performance validation, and software lifecycle processes is preferred.

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Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Siemens Healthineers' businesses, please visit our company page at Siemens Healthineers Canada.

The expected compensation for this position is:

Factors which may affect starting compensation within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

Siemens Healthineers offers a variety of health and wellness benefits including a flexible benefits plan, Defined Contribution Pension Plan, Registered Retirement Savings Plan matching contributions, plus a competitive paid time off program including vacation, company holidays, sick leave, and parental leave (all subject to eligibility requirements).

This information is provided per required laws and regulations. Applicants should apply via Siemens Healthineers external or internal careers site.

Equal Employment Opportunity Statement: Siemens Healthineers is committed to creating a diverse environment and is proud to be an equal opportunity employer. While we appreciate all applications we receive, we advise that only candidates under consideration will be contacted.

Accessibility: Siemens Healthineers is committed to excellence in serving all employees and customers, including people with disabilities. Siemens Healthineers will strive to ensure that policies and procedures established with respect to the provisions of its goods and services to persons with disabilities are consistent with the principles of dignity, independence, integration and equal opportunity as provided in the Accessibilities for Ontarians with Disabilities Act, 2005. Siemens Healthineers will continue to attempt to meet the needs of all its customers, including but not limited to persons with disabilities, in an effective and timely manner.

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