Senior Program Manager, SaMD

Whoop
Boston
Workplace: OnsiteFull timeUSD 155,000 - 185,000 annuallyFunction: Program & Project Management (PMO)Experience: 6-10 yearsSkills: ["Organizational skills","Communication","Stakeholder management","Risk management","Cross-functional coordination"]

Own end-to-end execution of Software as a Medical Device (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 milestones, coordinate parallel initiatives, build and maintain program plans, and identify/mitigate risks. Ensure compliance with design controls and documentation, including verification/validation, clinical studies, and DHF processes.

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FursaFursa
Whoop
Whoop
4 weeks ago

Senior Program Manager, SaMD

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Last checked: 13 hours agoStatus: Live

Job Summary

Own end-to-end execution of Software as a Medical Device (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 milestones, coordinate parallel initiatives, build and maintain program plans, and identify/mitigate risks. Ensure compliance with design controls and documentation, including verification/validation, clinical studies, and DHF processes.
Location: Boston
Workplace: Onsite
Employment Type: Full time
Job Function: Program & Project Management (PMO)
Seniority: Mid level

Key Responsibilities

  • •Drive execution of SaMD programs across the full product lifecycle, from development through regulatory submission and launch.
  • •Partner with cross-functional leaders to plan and deliver program milestones with Machine Learning, Product, Engineering, Clinical, Regulatory, and Quality.
  • •Coordinate multiple SaMD initiatives with an existing Program Manager to ensure alignment across timelines and dependencies.
  • •Build and maintain detailed program plans, tracking deliverables and identifying risks early.
  • •Coordinate compliance-related activities, including design controls, verification & validation, clinical studies, regulatory submission preparation, and DHF documentation; manage risks/blockers and escalate as needed.

Pay and Benefits

Salary: USD 155,000 - 185,000 annually
Equity and Bonus:Equity

Key Requirements

  • •6–10+ years of program or project management experience.
  • •Hands-on experience delivering at least one end-to-end SaMD program from development through regulatory submission/clearance.
  • •Knowledge of FDA regulatory pathways (e.g., 510(k), De Novo) and SaMD lifecycle, including design controls (21 CFR 820, ISO 13485).
  • •Experience working within or closely with Quality Management Systems (QMS), including standards such as IEC 62304 and ISO 14971.
  • •Experience coordinating cross-functionally across Product, Engineering, Clinical, and Regulatory teams, ideally in wearables/digital health/consumer health and clinical evidence generation.
Experience:6-10 yearsSaMDMedical devicesRegulated softwareWearablesDigital healthConsumer healthClinical evidence
Skills:Organizational skillsCommunicationStakeholder managementRisk managementCross-functional coordination
Tech Stack:FDA510(k)De Novo21 CFR 820ISO 13485IEC 62304ISO 14971QMSDesign controlsSaMDVerification & ValidationDHF

Company Brief

Whoop
Whoop designs and sells a subscription-based wearable fitness tracker and analytics platform that monitors recovery, strain, and sleep to optimize athletic performance and daily health for consumers and professional athletes.
Industry: Wearables
Company Size: Large (251 to 1,000 employees)
Growth: Scaleup
Valuation: Unicorn (USD 1B+)
Funding: Series E+
Headquarters: Boston, United States
Founded: 2012
WebsiteLinkedIn