Manager, Regulatory Affairs

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🕒 vor 4 Monaten

🏄 California – Remote

🏄 California – Remote

💵 $127.000 - $165.000 / Jahr

⏰ Vollzeit

🟠 Senior

🔴 Experte

🚔 Compliance

Jetzt Bewerben

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iRhythm Technologies, Inc.

WebsiteLinkedInAlle Stellen

1001 - 5000 Mitarbeiter

Gegründet 2006

⚕️ Krankenversicherung

🧬 Biotechnologie

Healthcare Insurance • Biotechnology • Medical Technology

iRhythm Technologies, Inc. ist ein Unternehmen für Medizintechnologie, das sich auf Lösungen für die Herzüberwachung spezialisiert hat. Ihr Flaggschiffprodukt, der Zio-EKG-Monitor, ist auf Patientenkomfort und Einhaltung ausgelegt und ermöglicht es Gesundheitsdienstleistern, präzise Diagnosen von Herzrhythmusstörungen durch fortschrittliche Datenanalyse und KI zu liefern. Der umfassende Service von iRhythm transformiert das Erlebnis der Herzüberwachung, erleichtert bessere Patientenergebnisse und effiziente Arbeitsabläufe für Gesundheitsprofis weltweit.

Beschreibung

• 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.

🎯 Anforderungen

• 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%

🏖️ Vorteile

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