Senior Program Manager, SaMD

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 teams to deliver against program milestones
• 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, and Regulatory submission preparation
• Manage Design History File (DHF) documentation and proactively address program blockers
• Help strengthen and scale program management processes as the SaMD portfolio expands

Requirements

• 6-10+ years of program or project management experience
• Hands-on experience managing at least one end-to-end SaMD program from development through regulatory clearance
• Deep familiarity with FDA regulatory pathways (e.g., 510(k), De Novo) and Design controls (21 CFR 820, ISO 13485)
• Experience working within or closely with Quality Management Systems (QMS)
• Understanding of key industry standards including IEC 62304 and ISO 14971
• Strong organizational, communication, and stakeholder management skills
• Technical or scientific background

Preferred Qualifications

• Experience in wearables, digital health, or consumer health products
• Experience supporting clinical evidence generation or clinical studies
• Proven ability to manage multiple concurrent programs effectively

About the Company

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.