Senior R&D Program Manager – Remote-Friendly SaMD

iRhythm Holdings, Inc.; San Francisco (CA); Hybrid; USD 212,000 - 254,000; Full time

Benefits offered by this job

Employee referral program

Job summary

iRhythm Technologies, Inc. seeks a Senior R&D Project Manager to lead and manage software design and development for clinical solutions.

You will lead a cross-functional team, ensuring regulatory and cybersecurity requirements are reflected in the software lifecycle, and participate in production release and health monitoring activities. Develop technical timelines, prioritize workstreams, and keep stakeholders aligned on goals, timelines, and compliance.

Qualifications

• Master’s degree in Electrical or Biomedical Engineering or related field.
• 5+ years of software project management in medical device applications.
• Experience with IEC 62304, IEC 62366, IEC 60601, ISO 14971, ISO 13485 and 21 CFR Part 820.
• Managing 510(k) submissions and regulatory submissions to FDA.
• US/intl regulations including FDA, EU MDR, PMDA, UKCA for SaMD.

Responsibilities

• Lead cross-functional teams to deliver clinical software solutions.
• Ensure regulatory and cybersecurity requirements are integrated into design and development.
• Develop timelines/roadmaps to meet program strategy, budget, scope and business needs.
• Coordinate stakeholders to align goals, timelines and compliance needs.
• Support regulatory submissions and DHF maintenance; guide risk management activities.

Skills

Technical project management

Agile methodologies

Cross-functional leadership

Regulatory compliance (SaMD)

FDA submissions (510(k))

Toolset: Smartsheet, Jira, Confluence,

Jama, Aha!

Education

Master's degree in Electrical/Biomedical Eng

Tools

Smartsheet

Jira

Confluence

Jama

Aha!

Job description

iRhythm Technologies, Inc. seeks a Senior R&D Project Manager to lead and manage software design and development for clinical solutions.

You will lead a cross-functional team, ensuring regulatory and cybersecurity requirements are reflected in the software lifecycle, and participate in production release and health monitoring activities. Develop technical timelines, prioritize workstreams, and keep stakeholders aligned on goals, timelines, and compliance.