Senior Program Manager, SaMD

United States·Bostonsenior

OperationsProject Manager

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Requirements Summary

Verification & validation, Clinical studies, Regulatory submission preparation, Design history file (DHF) documentation Identify and proactively manage program risks and blockers,

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OperationsProject Manager

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.

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