Manager, Quality Assurance – Regulatory Affairs

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🔥 1 minute ago

🤠 Texas – Remote

🤠 Texas – Remote

💵 $100.7k - $126k / 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 vendor-agnostic clinical surveillance and patient-monitoring platform that aggregates real-time waveforms, ECGs, alarms, and other clinical data from monitors, EMRs and medical devices and delivers them to clinicians via mobile and web applications. AirStrip’s products include solutions for patient monitoring, obstetrics (maternal/fetal monitoring), cardiology (12-lead ECGs, STEMI notifications), alarm management and analytics, telemetry optimization, and decision support. The platform emphasizes near-real-time waveform access, alarm triage/dispatch, diagnostic-quality ECG capture and secure EHR transmission, and meets industry security and HIPAA requirements.

📋 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 QSDs to assure compliance with 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 Quality Assurance and Regulatory Affairs expertise • Act as a team member of New Product Development or 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 Internal and Supplier Audits according to Company Audit Programs and applicable standards and regulations • 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 • Collaborate with team members and mentor others 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 details • Creative and innovative thinker • 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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