Senior Program Manager, Samd

Whoop Whoop · Consumer · Boston, MA · Product

Senior Program Manager to drive execution of Software as a Medical Device (SaMD) programs, partnering with cross-functional teams including Machine Learning, Product, and Engineering, to deliver regulated features from development through regulatory submission and launch within a healthcare context.

What you'd actually do

  1. Drive execution of SaMD programs across the full product lifecycle, from development through regulatory submission and launch
  2. Partner with Machine Learning, Product, Engineering, Clinical, Regulatory, and Quality to plan and deliver against program milestones
  3. Work alongside an existing Program Manager to coordinate multiple SaMD initiatives, ensuring alignment across timelines and dependencies
  4. Build and maintain detailed program plans, tracking progress against key deliverables and identifying risks early
  5. Support development in compliance with design controls and regulatory requirements, ensuring documentation and processes are followed

Skills

Required

  • 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

Nice to have

  • 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

What the JD emphasized

  • end-to-end SaMD programs
  • regulated features
  • FDA regulatory pathways
  • Design controls
  • Quality Management Systems (QMS)