Manager, Quality Assurance – Regulatory Affairs

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🔥 2 minutes ago

🤠 Texas – Remote

🤠 Texas – Remote

💵 $100.7k - $126k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 0%

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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

• Develop, implement, and maintain QSDs to assure compliance of the Company's Quality System with MDSAP, 21 CFR Part 820, and FDA guidance and regulations related to SaMDs • Participate in audits conducted by Notified and Regulatory bodies, providing professional support and expertise for Quality Assurance and Regulatory Affairs topics • Support New Product Development and Existing Product Enhancement teams throughout development of Design History Files, Technical Files, Risk Management, Clinical Evaluation, and Post-Market Surveillance Files • Participate in Nonconforming Product and Complaint Processes to identify, document, evaluate, segregate, and disposition nonconforming products and customer complaints • Resolve systemic product non-conformances through the CAPA Process • Participate in and ensure timely completion of Internal and Supplier Audits • Organize and coordinate CAPA, Complaints, Clinical Evaluation, and Post-Market Surveillance data collection, monitoring, analysis, and reporting for Management Review meetings • Maintain international authorizations including ISO 13485:2016, MDSAP, MDD/MDR certifications, UKCA, and CMDCAS registrations • Establish a compliance knowledge base for extracting compliance statistics and current regulations • Lead continuous improvement initiatives across AirStrip's Quality Management System • Mentor and collaborate with team members while driving quality, compliance, and operational excellence

🎯 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 thinking • Coaching and mentoring for direct reports • Continuous improvement for QMS • Proven compliance with current and applicable standards and regulations such as MDSAP, MDR, UKCA, ISO 13485, QMSR, etc. • Strong understanding of risk assessment

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