Manager, Quality Assurance & Regulatory Affairs

Job not on LinkedIn

🔥 16 minutes ago

🤠 Texas – Remote

🤠 Texas – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

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 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 • Participate in 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, 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 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 tracking current regulations • Build expertise on topics 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 upcoming MDR requirements • Maintain regulatory and quality compliance for AirStrip solutions in designated markets • Participate in responses to compliance questionnaires for Enterprise Users • 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 skills, written and verbal • Effective problem-solving skills; results-oriented • Outstanding attention to detail • Creative and innovative thinking • Coaching and mentoring skills for direct reports • Continuous improvement experience 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

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume