Senior R&D Program Lead – SaMD & Regulatory Compliance

iRhythm Technologies, 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. invites applications for a Senior R&D Project Manager to lead the design and development of clinical software solutions for iRhythm products.

You will drive cross-functional teams to ensure clinical needs are met while integrating regulatory and cybersecurity requirements into the software development lifecycle. You will develop technical roadmaps, manage budgets and schedules, support regulatory submissions, and reinforce Agile delivery across programs.

Qualifications

• Master’s degree in Electrical Engineering, Biomedical Engineering or related field.
• 5+ years of experience managing software development projects within medical device applications.
• Experience with IEC 62304, IEC 62366, IEC 60601, ISO 14971, ISO 13485 and 21 CFR Part 820; FDA submissions.

Responsibilities

• Lead cross-functional teams to meet regulatory and clinical requirements.
• Develop technical project timelines and roadmaps for programs.
• Oversee regulatory submissions, risk analysis, cybersecurity documents, and software validation.
• Promote agile delivery and manage DHF along regulatory standards.

Skills

Technical project management

Agile methodologies

Cross-functional leadership

Regulatory compliance

Risk management

Stakeholder communication

Education

Master’s degree in Electrical Engineering or Biomedical Engineering

Tools

Smartsheet

Atlassian Jira

Confluence

Jama

Aha!

Job description

iRhythm Technologies, Inc. invites applications for a Senior R&D Project Manager to lead the design and development of clinical software solutions for iRhythm products.

You will drive cross-functional teams to ensure clinical needs are met while integrating regulatory and cybersecurity requirements into the software development lifecycle. You will develop technical roadmaps, manage budgets and schedules, support regulatory submissions, and reinforce Agile delivery across programs.