Manager, Regulatory Affairs

iRhythm Technologies seeks a Manager of Regulatory Affairs to lead regulatory strategy and FDA submissions for cardiac wearable devices and software products. The role involves managing regulatory associates, developing compliance strategies, and ensuring adherence to global medical device standards across product lifecycles.

Responsibilities

• Develop and execute regulatory strategies for new and modified medical devices aligned with business objectives
• Manage regulatory team work planning, execution, guidance, and talent development
• Lead FDA submissions including 510(k)s and pre-submissions for wearable and SaMD products
• Serve as regulatory expert on AI, SaMD, and cybersecurity; establish compliance processes with stakeholders
• Lead EU MDR technical documentation and international regulatory filings for global submissions

Requirements

• Bachelor's degree in engineering, life sciences, or related field
• 8-10 years US/EU regulatory affairs experience, or 6 years with Master's degree
• Proficiency in 21 CFR 820, EU MDD/MDR, ISO 13485, IEC 62304, ISO 14971, and HIPAA
• Demonstrated experience authoring 510(k)s and managing FDA clearance processes
• Software as a Medical Device (SaMD) experience required
• New product development and risk-based regulatory strategy experience
• Wearable medical device experience preferred

Compensation: $127,000 - $165,000 base