Manager, Quality Assurance – Regulatory Affairs

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🔥 0 minutes ago

🤠 Texas – Remote

🤠 Texas – Remote

💵 $110k - $137.8k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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AirStrip

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2006

🏥 Healthcare

☁️ SaaS

💰 $50M Debt Financing - Airstrip Technologies on 2025-10

Healthcare • SaaS

AirStrip is a healthcare software company that provides clinical surveillance and remote patient-monitoring solutions for hospitals and care teams. Its vendor-agnostic platform aggregates and displays near-real-time waveforms, diagnostic-quality ECGs (including 12-lead and cardiac rhythm strips), maternal/fetal monitoring, alarm management and alarm analytics, decision support, and telemetry optimization via native mobile apps and the web. AirStrip’s products are designed for use across cardiology, obstetrics, intensive care, emergency, and telemetry workflows; the platform emphasizes HIPAA compliance and industry-standard security (ISO 27001) for clinical integration with EMRs and bedside devices. AirStrip was also named one of the world’s Top HealthTech Companies by TIME in 2025.

📋 Description

• Lead continuous improvement initiatives across AirStrip’s Quality Management System • Ensure compliance with global regulatory standards, including MDSAP, MDR, UKCA, ISO 13485, and QMSR • Develop, implement, and maintain Quality System Documents to ensure compliance with MDSAP, 21 CFR Part 820, FDA guidance, and SaMD regulations • Participate in audits conducted by notified and regulatory bodies • Support New Product Development and Existing Product Enhancement teams throughout Design History File, Technical File, risk management, clinical evaluation, and post-market surveillance activities • Participate in nonconforming product and customer complaint processes • Resolve systemic product nonconformances through the CAPA process • Participate in and ensure timely internal and supplier audits • Organize and coordinate CAPA, complaints, clinical evaluation, and post-market surveillance data for Management Review meetings • Maintain international authorizations and registrations, including ISO 13485:2016, MDSAP, MDD/MDR, UKCA, and CMDCAS • Establish a compliance knowledge base for extracting compliance statistics and tracking current regulations • Build expertise in areas such as cloud computing • Directly supervise the QA/RA Associate Project Manager • Implement proactive compliance decisions, including European Conformity (CE) requirements • Upgrade processes to meet MDR requirements • Maintain regulatory and quality compliance of AirStrip solutions in designated markets • Participate in responses to Enterprise User compliance questionnaires • Ensure corporate SOPs comply with FDA, CE, MDSAP, ISO, DIACAP, and general quality principles

🎯 Requirements

• Bachelor's degree in Healthcare, IT, Quality, or related field; commensurate experience will be considered in lieu of degree • Minimum 5 years of experience managing QA / RA in a medical device company • Minimum 5 years of experience understanding guidance from FDA and international regulatory agencies • Strong organizational, planning, and follow-up skills • Strong interpersonal communication, written and verbal • Effective problem-solving skills; results-oriented • Outstanding attention to detail • Creative and innovative thinker • Coaching and mentoring for direct reports • Continuous improvement for QMS • Proven compliance with MDSAP, MDR, UKCA, ISO 13485, QMSR, and other applicable standards and regulations • Strong understanding of risk assessment

🏖️ Benefits

• Up to 30% travel to company office locations and client sites as needed for corporate and client site meetings

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