# Senior Program Manager, SaMD

**Company:** [WHOOP](https://hotfix.jobs/companies/whoop)
**Location:** Boston, MA
**Role:** Technical Program Management
**Experience:** 6+ years
**Skills:** Fda 510(K), De Novo, 21 Cfr 820, Iso 13485, Iec 62304, Iso 14971, Design Controls, Qms, Samd, Regulatory Submission, Clinical Studies, Dhf
**Posted:** 2026-05-01

> Leads execution of Software as a Medical Device (SaMD) programs from development to regulatory submission and launch. Coordinates cross-functionally with Engineering, Product, Clinical, and Regulatory teams, ensuring compliance with FDA pathways and design controls. Requires 6-10+ years experience with end-to-end SaMD programs.

## Job Description

## 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

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