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Senior Program Manager, SaMD

BostonOn-siteFull-time

AI Summary

Senior Program Manager for SaMD responsible for driving end-to-end development, regulatory submission, and launch of software as a medical device programs with cross-functional leadership and risk management.

About this role

WHOOP is an advanced health and fitness wearable on a mission to unlock human performance. We empower our members to improve their health and perform at a higher level through a deeper understanding of their bodies and daily lives.

We are looking for a Senior Program Manager, SaMD to join our growing team and help scale the execution of our Software as a Medical Device programs. This role will partner closely with an existing Program Manager and cross-functional leaders to drive the successful delivery of regulated features.

This is an execution-focused role for someone who has experience working on end-to-end SaMD programs and can operate effectively within an established but evolving system.

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
  • 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

    • 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
  • Background in a technical or scientific field

    • Skills

    Clinical Study CoordinationCross-functional LeadershipDesign Controls (21 CFR 820, ISO 13485)Design History File (DHF)FDA Pathways (510(k), De Novo)IEC 62304ISO 14971Lifecycle ManagementProgram Planning And TrackingQuality Management Systems (QMS)Regulatory Compliance DocumentationRegulatory DocumentationRegulatory Submission PlanningRegulatory Submission PreparationRisk ManagementSaMD Program ManagementVerification & Validation PlanningWearables / Digital Health Domain

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