Lead SaMD Program Manager — Regulatory Delivery & Launch

United States Digital Space LLC; Boston (MA); On-site; USD 155,000 - 185,000; Full time

Job summary

United States Digital Space LLC is seeking aSenior Program Manager, SaMD in Boston to drive end-to-end SaMD programs from development through regulatory submission and launch. You will partner with ML, Product, Engineering, Clinical, Regulatory, and Quality teams to meet milestones and manage risks.

This execution-focused role requires experience across multiple concurrent SaMD initiatives and a strong grasp of 21 CFR 820, ISO 13485, IEC 62304, and ISO 14971.

Qualifications

• 6–10+ years of program or project management experience.
• Hands-on experience with at least one end-to-end SaMD program.
• Familiarity with FDA pathways and 21 CFR 820 Design controls.
• Experience with Quality Management Systems (QMS).

Responsibilities

• Drive execution of SaMD programs across the full product lifecycle from development to regulatory submission and launch.
• Partner with ML, Product, Engineering, Clinical, Regulatory, and Quality to deliver milestones.
• Coordinate multiple SaMD initiatives and align timelines and dependencies.
• Build and maintain detailed program plans and track progress against deliverables.
• Support design controls and regulatory documentation compliance.
• Coordinate verification, validation, clinical studies, regulatory submissions, and DHF work.
• Identify and manage risks and blockers; escalate as needed.
• Facilitate clear communication and regular program updates across stakeholders.
• Scale program management processes as the SaMD portfolio grows.

Skills

Program management

SaMD

Regulatory knowledge

QMS

Design controls

Job description

United States Digital Space LLC is seeking aSenior Program Manager, SaMD in Boston to drive end-to-end SaMD programs from development through regulatory submission and launch. You will partner with ML, Product, Engineering, Clinical, Regulatory, and Quality teams to meet milestones and manage risks.

This execution-focused role requires experience across multiple concurrent SaMD initiatives and a strong grasp of 21 CFR 820, ISO 13485, IEC 62304, and ISO 14971.