Manager, Regulatory Affairs

About the Role Manager, Regulatory Affairs at iRhythm is responsible for developing and executing regulatory strategies for new and modified medical devices, leading FDA submissions, and ensuring lifecycle regulatory compliance for wearables and SaMD products. This role also involves team leadership, regulatory SME duties, and cross-functional collaboration to deliver compliant cardiac health solutions. What You'll Do

• Develop and execute regulatory strategies for new and modified medical devices in line with business objectives and product plans.
• Manage regulatory associates, including work planning, guidance, execution, and talent development.
• Lead FDA submissions (510(k) or pre-submissions) with the team, including wearable devices and AI SaMD.
• Serve as Regulatory SME and review/approve advertising and promotional materials to ensure regulatory compliance.
• Oversee regulatory strategy and processes for product lifecycle management; lead EU MDR Technical Documentation and other international submissions for wearables and SaMD.
• Develop regulatory tools and matrices to increase team efficiency; prepare international and domestic regulatory filings/registrations; interact with regulatory authorities to seek submission clearance.
• Review and approve product design changes to maintain regulatory compliance for significant changes; author or revise SOPs within the Quality System.
• Monitor the impact of changing global regulations on submission strategies and registrations; support internal and external audits; travel as required. What We're Looking For
• BA or BS in engineering, life sciences, or related field.
• 8-10 years minimum US/EU regulatory affairs experience with a Bachelor’s; 6 years minimum with a Master’s.
• 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 with management of 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, organizational, and communication (written and oral) skills.
• Willingness to travel when required, approximately 5-10%. Nice to Have
• Familiarity with LATAM, Asia Pacific, EMEA regulatory environments; cross-functional collaboration experience; audit support.
• Experience leading regulatory teams and establishing scalable regulatory processes for AI, SaMD, and cybersecurity areas. Compensation & Benefits
• Salary range: $127,000 - $165,000 per year.
• Benefits include medical, dental and vision insurance, paid holidays and paid time off, 401K with company match, Employee Stock Purchase Plan, and additional company offerings.
• Remote work option for US-based candidates.