Manager, Regulatory Affairs

Role Overview

As a Manager, Regulatory Affairs at iRhythm, you will develop and execute regulatory strategies for new and modified medical devices, manage regulatory associates, and lead FDA submissions. You will be responsible for ensuring regulatory compliance and developing regulatory tools and matrices to enhance team efficiency and capabilities.

What You Will Do

Your day-to-day responsibilities will include developing regulatory strategies, managing regulatory associates, leading FDA submissions, and reviewing and approving advertising and promotional materials. You will also be responsible for preparing international and domestic regulatory filings/registrations and interacting with regulatory authorities.

Why It Might Be a Fit

This role requires a strong background in regulatory affairs, with a minimum of 8-10 years of experience in US and/or EU regulatory affairs. You will need to have demonstrated competency in operating under 21 CFR 820, EU MDD/MDR, ISO 13485, IEC 62304, ISO 14971, HIPAA, and other medical device industry standards. You will also need to have experience with software as a medical device (SaMD) and new product development.

Requirements

• BA or BS degree in engineering, life sciences, or a related field
• Minimum 8-10 years of US and/or EU regulatory affairs experience
• Demonstrated competency in operating under 21 CFR 820, EU MDD/MDR, ISO 13485, IEC 62304, ISO 14971, HIPAA, and other medical device industry standards
• Software as a medical device (SaMD) experience
• New product development experience
• Authorship of 510(k)s and experience with management of FDA reviews to gain clearance
• Demonstrated competency in developing risk-based regulatory strategies

Benefits

• Medical, dental, and vision insurance
• Paid holidays
• Paid time off
• 401K (w/ company match)
• Employee Stock Purchase Plan
• Annual organizational/cultural committee events