Job Summary:
WHOOP is an advanced health and fitness wearable on a mission to unlock human performance. They are looking for a Senior Program Manager, SaMD to help scale the execution of their Software as a Medical Device programs, partnering closely with cross-functional leaders to drive successful delivery of regulated features.
Responsibilities:
โข Drive execution of SaMD programs across the full product lifecycle, from development through regulatory submission and launch
โข Partner with Machine Learning, Product, Engineering, Clinical, Regulatory, and Quality to plan and deliver against program milestones
โข Work alongside an existing Program Manager to coordinate multiple SaMD initiatives, ensuring alignment across timelines and dependencies
โข Build and maintain detailed program plans, tracking progress against key deliverables and identifying risks early
โข Support development in compliance with design controls and regulatory requirements, ensuring documentation and processes are followed
โข Coordinate cross-functional activities including: Verification & validation, Clinical studies, Regulatory submission preparation, Design history file (DHF) documentation
โข Identify and proactively manage program risks and blockers, escalating as needed
โข Facilitate clear and consistent communication across stakeholders, including regular program updates
โข Help strengthen and scale program management processes as WHOOP expands its SaMD portfolio
Qualifications:
Required:
โข 6 - 10+ years of program or project management experience
โข Hands-on experience working on at least one end-to-end SaMD program (from development through regulatory submission/clearance)
โข Familiarity with: FDA regulatory pathways (e.g., 510(k), De Novo), Design controls (21 CFR 820, ISO 13485) and SaMD development lifecycle
โข Experience working within or closely with Quality Management Systems (QMS)
โข Understanding of key standards such as: IEC 62304 & ISO 14971
โข Proven ability to coordinate across Product, Engineering, Clinical, and Regulatory teams
โข Strong organizational, communication, and stakeholder management skills
โข Experience in wearables, digital health, or consumer health products
โข Experience supporting clinical evidence generation or studies
โข Experience working across multiple concurrent programs
โข Background in a technical or scientific field
Company:
WHOOP provides wearable fitness technology and a subscription platform that tracks physiological data for health and performance insights. Founded in 2012, the company is headquartered in Boston, USA, with a team of 501-1000 employees. The company is currently Late Stage.