Manager, Regulatory Affairs

Career-defining. Life-changing. At iRhythm , you’ll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what’s possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career About This Role: Responsibilities include: Developing and executing regulatory strategies for new and modified medical devices in line with business objectives Manage regulatory associates as needed, responsible for team’s work planning, guidance, execution and talent development Lead FDA submissions (510(k) or pre-submissions) with the team, including wearable devices, as well as artificial intelligence (AI) Software as a Medical Device (SaMD) products Key Regulatory SME and review & approve advertising and promotional materials to ensure regulatory compliance Regulatory strategy and processes for product life cycle management Lead EU MDR Technical Documentation and other international submissions for both wearable devices and SaMD Developing regulatory tools and matrices to enhance team efficiency and capabilities as needed Lead regulatory expert in AI, SaMD, Cybersecurity, collaborating with stakeholders establishing necessary processes to ensure regulation compliance Preparing international and domestic regulatory filings/registrations in line with established project timelines Interacting with regulatory authorities during the development and review process to ensure submission clearance Review and approve product design changes to maintain regulatory compliance for significant changes Author or revise SOPs to improve regulatory compliance within the Quality