Manager, Regulatory Affairs

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🕒 Fevereiro 6

🏄 California – Remoto

🏄 California – Remote

💵 $127.000 - $165.000 / ano

⏰ Tempo Integral

🟠 Sênior

🔴 Especialista

🚔 Conformidade

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iRhythm Technologies, Inc.

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2006

⚕️ Seguro de Saúde

🧬 Biotecnologia

Healthcare Insurance • Biotechnology • Medical Technology

A iRhythm Technologies, Inc. é uma empresa de tecnologia em saúde que se especializa em soluções de monitoramento cardíaco. Seu produto principal, o monitor Zio ECG, é projetado para o conforto e aderência do paciente, permitindo que os profissionais de saúde forneçam diagnósticos precisos de arritmias através de análise avançada de dados e inteligência artificial. O serviço abrangente da iRhythm transforma a experiência de monitoramento cardíaco, facilitando melhores resultados para os pacientes e fluxos de trabalho eficientes para profissionais de saúde em todo o mundo.

Descrição

• 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 System • Monitoring the impact of changing global regulations on submission strategies & registrations • Support external and internal audits • Perform other regulatory-related duties as assigned.

🎯 Requisitos

• 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 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 skills • Exceptional organizational skills • Exceptional communication (written and oral) skills • Willingness to travel when required, approximately 5-10%

🏖️ Benefícios

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