Clinical Evidence Planning and Evaluations Manager

This is a fully remote position, open to applicants in Canada.

📋 Description

• Develop and implement clinical evidence strategies for Software as a Medical Device (SaMD), digital health, and AI-driven solutions throughout the product lifecycle.

• Create and manage Clinical Evaluation Plans and Reports (CEP/CER) as well as Post-Market Clinical Follow-up Plans and Reports (PMCFP/PMCFR).

• Collaborate with Regulatory Affairs, Quality, Product Management, Risk Management, Engineering, and Medical Affairs to establish and fulfill clinical evidence requirements.

• Oversee evidence generation activities, including literature reviews, clinical performance evaluations, real-world evidence assessments, and post-market surveillance efforts.

• Assist in clinical benefit-risk evaluations, intended use validation, and substantiating product claims.

• Track post-market clinical data and emerging evidence to pinpoint gaps, risks, and opportunities for ongoing enhancement.

• Facilitate global regulatory compliance and market access for Varian devices in radiation oncology and interventional oncology.

⛳️ Requirements

• Proficient understanding of Clinical Evaluation and Post-Market Clinical Follow-up requirements under the European Union Medical Device Regulation (EU MDR), especially for software-based medical devices.

• A Master's degree or higher in Biomedical Engineering, Medical Physics, Computer Science, Health Sciences, Public Health, Biostatistics, or a related field; relevant experience may be considered.

• Over 3 years of experience in clinical evaluation, clinical evidence generation, medical devices, SaMD, digital health, or a related area.

• Experience in assessing clinical data, scientific literature, and real-world evidence to support regulatory and business goals.

• Familiarity with Software as a Medical Device (SaMD), digital health technologies, AI-enabled medical devices, or healthcare software solutions.

• Knowledge of clinical evidence generation, clinical performance evaluation, and post-market surveillance principles.

• Excellent scientific writing, critical thinking, and communication abilities.

• Experience with AI/ML-enabled medical technologies, clinical performance validation, and software lifecycle processes is a plus.

• Capability to work autonomously in a remote environment.

🏝️ Benefits

• Flexible benefits plan.

• Defined Contribution Pension Plan.

• Registered Retirement Savings Plan with matching contributions.

• Competitive paid time off program.

• Vacation.

• Company holidays.

• Sick leave.

• Parental leave.