Whoop
Senior Program Manager, SaMD
$155K–$185KFull-time · Boston, MA
✓ Verified live on the employer's own system · added 99 days ago
Senior · 6+ yrs exp
Requirements
Experience: 6+ years
Skills & tools Fitness Training Management Project Management
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Full job description 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 Coordinate 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 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 Background in a technical or scientific field
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