Whoop
Senior Program Manager, SaMD
Boston, MA · Senior · Full-time
Sponsorship not specified$155k-$185kDetected 12 days ago
Machine LearningProduct ManagementProject ManagementStakeholder ManagementClinical TrialsFDA RegulatoryMedical DevicesCommunication
About the role
- 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.
- Interested in the role, but don't meet every qualification?
- The U.S. base salary range for this full-time position is $155,000 - $185,000.
Responsibilities
- Drive execution of SaMD programs across the full product lifecycle, from development through regulatory submission and launch
- 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
- Familiarity with: FDA regulatory pathways (e.g., 510(k), De Novo), Design controls (21 CFR 820, ISO 13485) and SaMD development lifecycle
- This role will partner closely with an existing Program Manager and cross-functional leaders to drive the successful delivery of regulated features.
Requirements
- 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)
- Experience working within or closely with Quality Management Systems (QMS)
- Proven ability to coordinate across Product, Engineering, Clinical, and Regulatory teams
- Experience supporting clinical evidence generation or studies
- Experience working across multiple concurrent programs
- The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office.
Compensation
- The U.S. base salary range for this full-time position is $155,000 - $185,000.
Benefits
- 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.
- Experience in wearables, digital health, or consumer health products
- Partner with Machine Learning, Product, Engineering, Clinical, Regulatory, and Quality to plan and deliver against program milestones
This listing is sourced directly from Whoop's careers page and normalized into a canonical job model.