Clinical AI Data Manager: Ultrasound & Regulatory

NeuroLogica Corp.; United States; In loco; USD 130.000 - 165.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical coverage

Dental coverage

Disability insurance

401k with company match

Health savings programs

Pet insurance

Paid time off

Tuition reimbursement

Descrizione del lavoro

Samsung HME America is seeking a Clinical AI Data Manager to lead planning, coordination, and execution of AI algorithm development initiatives from data acquisition through regulatory submission. You will connect clinical stakeholders with AI R&D engineers, regulatory teams, and external partners to ensure on-time, on-budget delivery, with up to 70% travel and prior ultrasound experience preferred.

The role requires strong project management, regulatory knowledge, and data workflow

Competenze

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

Mansioni

• Own end-to-end data planning for AI algorithm development and regulatory submission.
• Coordinate between AI R&D, product, regulatory affairs, legal, and finance to drive alignment.
• Manage budgets, identify variances, and escalate risks and delays.
• Develop documentation and status reports for stakeholders.
• Oversee data collection, annotation, and quality benchmarks with clinical insights teams.
• Oversee the 510(k) data pipeline and coordinate data allocation for regulatory needs.

Conoscenze

Clinical ultrasound

Data management

Project management

Regulatory knowledge

Budget management

Cross-functional coordination

Strumenti

Excel

Word

PowerPoint

Outlook

Descrizione del lavoro

Samsung HME America is seeking a Clinical AI Data Manager to lead planning, coordination, and execution of AI algorithm development initiatives from data acquisition through regulatory submission. You will connect clinical stakeholders with AI R&D engineers, regulatory teams, and external partners to ensure on-time, on-budget delivery, with up to 70% travel and prior ultrasound experience preferred.

The role requires strong project management, regulatory knowledge, and data workflow