Senior Program Manager (SaMD)

TL;DR

Senior Program Manager (SaMD): Driving the execution of Software as a Medical Device programs through the full product lifecycle from development to regulatory submission with an accent on regulatory compliance and cross-functional coordination. Focus on managing FDA regulatory pathways, design controls, and the delivery of regulated features for health wearables.

Location: On-site in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office.

Salary: $155,000 - $185,000

Company

hirify.global is an advanced health and fitness wearable company on a mission to unlock human performance through deeper body understanding.

What you will do

• Drive execution of SaMD programs from development through regulatory submission and launch.
• Partner with Machine Learning, Product, Engineering, Clinical, Regulatory, and Quality teams to deliver milestones.
• Build and maintain detailed program plans, tracking progress and identifying risks early.
• Ensure development compliance with design controls and regulatory requirements.
• Coordinate verification, validation, clinical studies, and Design History File (DHF) documentation.
• Facilitate clear communication across stakeholders and scale program management processes.

Requirements

• 6-10+ years of program or project management experience.
• Hands-on experience with at least one end-to-end SaMD program (development through regulatory clearance).
• Familiarity with FDA regulatory pathways (510(k), De Novo), Design controls (21 CFR 820, ISO 13485), and SaMD lifecycle.
• Experience with Quality Management Systems (QMS) and standards such as IEC 62304 & ISO 14971.
• Background in a technical or scientific field.
• Must be based in or prepared to relocate to Boston, MA.

Culture & Benefits

• Competitive base salary and a generous equity package.
• Comprehensive corporate benefits.
• Mission-driven environment focused on human performance and health.
• Opportunity to work with a growing team in the digital health and wearables space.