Senior Program Manager, SaMD

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. 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 QUALIFICATIONS: - - 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 This role is based in the WHOOP office located in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office. 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. WHOOP is an Equal Opportunity Employer and participates in E-verify https://www.e-verify.gov/to determine employment eligibility The WHOOP compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values. At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company’s long-term growth and success. The U.S. base sa ... (truncated, view full listing at source)