Senior Program Manager (SaMD)

• 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

Benefits

• Flexible Vacation: WHOOP has a flexible vacation policy that allows you to unwind, laptop-free, when you need it most.
• Focus on Family: We offer 18 weeks paid parental leave, plus an additional 2 weeks to gradually return to work.
• Get Invested: In addition to a competitive base salary and 401k, you’re eligible to receive stock options to share in the future of WHOOP.
• WHOOP +1: Everyone on the team gets a complimentary WHOOP membership—plus another membership to share with a loved one.
• Health Matters: Our competitive benefits package covers medical, dental, and vision, in addition to mental health services, life and disability insurance, and more.
• Find Your Fit: Full-time employees get $500 a year to spend on wellness in whatever way they see fit, from fitness classes and memberships, to recovery services.
• It Pays to Sleep: Our Sleep Performance Program incentivizes employees to get more sleep. Log an average sleep performance of 85% or higher for the month and get a $100 bonus.
• Location, Location, Location: You can’t beat the views from the rooftop of One Kenmore Square. Feel inspired daily as you work, enjoy free snacks and coffee, and collaborate in the heart of Boston.- Experience working within or closely with Quality Management Systems (QMS)
• Experience working across multiple concurrent programs
• Familiarity with: FDA regulatory pathways (e.g., 510(k), De Novo), Design controls (21 CFR 820, ISO 13485) and SaMD development lifecycle
• 6 - 10+ years of program or project management experience
• Background in a technical or scientific field
• Hands-on experience working on at least one end-to-end SaMD program (from development through regulatory submission/clearance)
• Proven ability to coordinate across Product, Engineering, Clinical, and Regulatory teams
• Experience supporting clinical evidence generation or studies
• Strong organizational, communication, and stakeholder management skills
• Understanding of key standards such as: IEC 62304 & ISO 14971
• Experience in wearables, digital health, or consumer health products
• Interested in the role, but don’t meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply