Manager, Regulatory Affairs

About This Role Developing and executing regulatory strategies for new and modified medical devices in line with business objectives Managing regulatory associates, responsible for team’s work planning, guidance, execution and talent development Leading FDA submissions (510(k) or pre-submissions) with the team, including wearable devices and AI Software as a Medical Device (SaMD) products Serving as Key Regulatory SME and reviewing & approving advertising and promotional materials to ensure regulatory compliance Defining regulatory strategy and processes for product life cycle management Leading EU MDR Technical Documentation and other international submissions for wearable devices and SaMD Developing regulatory tools and matrices to enhance team efficiency and capabilities as needed Acting as regulatory expert in AI, SaMD, Cybersecurity, collaborating with stakeholders to establish necessary processes for regulation compliance Preparing international and domestic regulatory filings/registrations in line with established project timelines Interacting with regulatory authorities during development and review processes to ensure submission clearance Reviewing and approving product design changes to maintain regulatory compliance for significant changes Authoring or revising SOPs to improve regulatory compliance within the Quality System Monitoring the impact of changing global regulations on submission strategies & registrations Supporting external and internal audits Performing other regulatory-related duties as assigned Qualifications BA or BS degree in engineering, life sciences, or a related field required >8‑10 years minimum of US and/or EU regulatory affairs experience with a Bachelor’s degree; 6 years minimum of US and/or EU regulatory affairs experience with a Master’s degree 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 required New product development experience required Authorship of 510(k)s and experience managing FDA reviews to gain clearance required Demonstrated competency in developing risk‑based regulatory strategies required Wearable medical device experience preferred Familiarity with global medical device regulations (LATAM, Asia Pac, EMEA, etc.) preferred Audit support experience preferred Strong project management skills Exceptional problem‑solving skills Exceptional organizational skills Exceptional communication (written and oral) skills Willingness to travel when required, approximately 5‑10% Benefits Full‑time position with competitive salary package and excellent benefits including medical, dental and vision insurance, paid holidays and paid time off 401(k) with company match Employee Stock Purchase Plan Annual organizational/cultural committee events and more Location Remote – US EEO Statement iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws. iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. #J-18808-Ljbffr