Clinical AI Program Manager: Data & Regulatory

Samsung Healthcare USA; United States; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical insurance

401k retirement plan

Paid time off

Job summary

Samsung HME America is seeking a Clinical AI Project Manager to lead planning, coordination, and execution of AI algorithm development initiatives from data acquisition through regulatory submission.

The role connects clinical stakeholders, AI R&D engineers, regulatory teams, and external partners to ensure on-time, on-budget delivery compliant with requirements, with preferred ultrasound experience.

Qualifications

• Experience in clinical project management, ideally within a medical device, health tech, or clinical AI environment.
• Clinical ultrasound experience is strongly preferred; familiarity with ultrasound imaging workflows, terminology, and clinical applications is a significant advantage.
• Working knowledge of FDA regulatory submissions (e.g., 510(k)) and IRB processes.
• Demonstrated ability to manage multiple concurrent workstreams, budgets, and cross-functional stakeholders in a fast-paced environment.
• Strong communication and relationship-building skills, with experience working alongside clinical, engineering, and legal teams.

Responsibilities

• Own end-to-end data planning for AI algorithm development, including scope, milestones, timelines, and resources across all phases from data collection through regulatory submission.
• Serve as the primary coordination point between AI R&D, product, regulatory affairs, legal, and finance, driving alignment and removing blockers.
• Manage and track project budgets; identify variances and elevate risks and delays to management.
• Establish and maintain a continuous feedback loop between clinical and engineering teams, preserving clinical relevance throughout algorithm development.
• Develop and maintain project documentation, status reports, and communication artifacts for internal and external stakeholders.

Skills

Clinical project management

Regulatory experience

Ultrasound experience

Cross-functional coordination

Strong communication

Tools

Excel

Word

PowerPoint

Outlook

Job description

Samsung HME America is seeking a Clinical AI Project Manager to lead planning, coordination, and execution of AI algorithm development initiatives from data acquisition through regulatory submission.

The role connects clinical stakeholders, AI R&D engineers, regulatory teams, and external partners to ensure on-time, on-budget delivery compliant with requirements, with preferred ultrasound experience.