Manager, Quality Assurance – Regulatory Affairs

AirStrip

. Lead continuous improvement initiatives across AirStrip’s Quality Management System .

Posted 11/9/2026full-timeRemote • Texas • United StatesMid-LevelSenior💰 $110,010 - $137,750 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Management Systems and regulatory compliance, including MDSAP, MDR, and ISO 13485. Proven ability to lead continuous improvement initiatives and manage quality assurance and regulatory affairs in the medical device industry.

Highest-signal resume keywords

Quality Management System LeadershipRegulatory Compliance ExpertiseCAPA Process ManagementRisk Assessment UnderstandingTeam Coaching and Mentoring

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality System DocumentationRegulatory Standards ComplianceAudit ParticipationNonconformance ResolutionClinical EvaluationPost-Market SurveillanceContinuous ImprovementData Organization and CoordinationProcess UpgradingCompliance Statistics Tracking

Soft Skills

Strong Organizational SkillsEffective Problem-SolvingInterpersonal CommunicationAttention to DetailCreative Thinking

Tools & Technologies

Cloud Computing

Certifications & Qualifications

ISO 13485:2016MDSAPMDRUKCAFDA Guidance

Industry Keywords

Medical DeviceQuality AssuranceRegulatory AffairsDesign History FileTechnical FileRisk ManagementCustomer Complaint ProcessesSupplier AuditsEnterprise User ComplianceGeneral Quality Principles

Tech Stack

Tools & technologies

Cloud

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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