Teams at iRhythm Technologies

Lead the validation and compliance of non-product software used in medical device development. Responsibilities include defining validation strategies, ensuring compliance with FDA and ISO standards, and cross-functional collaboration.

The manager will develop regulatory strategies for medical devices, manage a regulatory team, lead FDA submissions, and ensure compliance with global regulations.

Partner with senior leaders across Manufacturing, Supply Chain, Quality and Regulatory to drive workforce planning, org design, change initiatives, talent reviews, succession planning, and people risk mitigation. Serve as a strategic advisor, collaborate with HR COEs on compensation, employee relations, performance management, and talent acquisition, and deliver data-driven organizational effectiveness and development solutions.