Senior Program Manager, SaMD

Whoop•Boston, MA

10d•$155,000 - $185,000•Onsite

About The Position

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.

Requirements

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

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