Manager, Quality Assurance – Regulatory Affairs

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🔥 0 minutes ago

🤠 Texas – Remote

🤠 Texas – Remote

⏰ 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 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 across Design History Files, Technical Files, Risk Management, Clinical Evaluation, and Post-Market Surveillance activities • Participate in nonconforming product and complaint processes, including identification, documentation, evaluation, segregation, and disposition • 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 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 compliance statistics and current regulations • Build expertise in topics such as cloud computing • Directly supervise the QA/RA Associate Project Manager • Implement proactive compliance decisions, including European Conformity requirements • Upgrade processes to meet MDR requirements • Maintain regulatory and quality compliance for 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 thinking • Coaching and mentoring for direct reports • Continuous improvement for QMS • Proven compliance with applicable standards and regulations such as MDSAP, MDR, UKCA, ISO 13485, and QMSR • 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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