Senior Program Manager, SaMD

📋 Description

• Drive SaMD program execution from development to regulatory launch.
• Partner with ML, Product, Engineering, Clinical, Regulatory, and Quality to plan milestones.
• Coordinate multiple SaMD initiatives with an existing Program Manager.
• Build and maintain detailed program plans, track progress, identify risks early.
• Support design controls and regulatory requirements, ensuring docs and processes are followed.
• Coordinate cross-functional activities: Verification & Validation, Clinical studies, Regulatory prep, DHF documentation.

🎯 Requirements

• 6-10+ years of program/project management experience.
• Hands-on SaMD program experience from development through regulatory clearance.
• Familiarity with FDA pathways (510(k), De Novo) and design controls (21 CFR 820, ISO 13485).
• Experience with Quality Management Systems (QMS).
• Understanding IEC 62304 and ISO 14971.
• Background in a technical or scientific field.

🎁 Benefits

• Equal Opportunity Employer; participates in E-verify to determine employment eligibility.
• Competitive base salary, meaningful equity, and benefits package.
• Equity serves as a key differentiator aligning employees with long-term growth.
• Inclusive, diverse environment valuing character and experience.