Senior Program Manager, SaMD

Responsibilities

• Drive execution of SaMD programs across the full product lifecycle, from development through regulatory submission and launch
• Partner with Machine Learning, Product, Engineering, Clinical, Regulatory, and Quality to plan and deliver against program milestones
• Work alongside an existing Program Manager to coordinate multiple SaMD initiatives, ensuring alignment across timelines and dependencies
• Build and maintain detailed program plans, tracking progress against key deliverables and identifying risks early
• Support development in compliance with design controls and regulatory requirements, ensuring documentation and processes are followed
• Cover cross-functional activities including: Verification & validation, Clinical studies, Regulatory submission preparation, Design history file (DHF) documentation
• Identify and proactively manage program risks and blockers, escalating as needed
• Facilitate clear and consistent communication across stakeholders, including regular program updates
• Help strengthen and scale program management processes as WHOOP expands its SaMD portfolio

Qualifications

• 6 - 10+ years of program or project management experience
• Hands-on experience working on at least one end-to-end SaMD program (from development through regulatory submission/clearance)
• Familiarity with: FDA regulatory pathways (e.g., 510(k), De Novo), Design controls (21 CFR 820, ISO 13485) and SaMD development lifecycle
• Experience working within or closely with Quality Management Systems (QMS)
• Understanding of key standards such as: IEC 62304 & ISO 14971
• Proven ability to coordinate across Product, Engineering, Clinical, and Regulatory teams
• Strong organizational, communication, and stakeholder management skills
• Experience in wearables, digital health, or consumer health products
• Experience supporting clinical evidence generation or studies
• Experience working across multiple concurrent programs