Vice President, Quality Assurance & Regulatory Affairs | AirStrip

Are you ready to link your passion with a purpose? At AirStrip, we build technology that enables clinicians to diagnose earlier than ever before, accelerate life-saving interventions, reduce the cost of care, and save lives.We provide mobile-first clinical surveillance and alarm communication management technology that unlocks siloed data from patient monitors and transforms it into contextually rich information easily accessible on mobile devices and the Web. We’re seeking innovative thinkers who love doing meaningful work. If you’re looking to bring your skills and expertise to a growing technology company, it’s time for you to join us!AirStrip is adding a Vice President of Quality Assurance and Regulatory Affairs (QA/RA) to our team. This role is a strategic executive leader responsible for establishing, maintaining, and advancing AirStrip’s global Quality Management System (QMS) and regulatory compliance framework in support of its Software-as-a-Medical-Device (SaMD) product portfolio. This role ensures alignment with applicable regulatory requirements including FDA Quality Management System Regulation (21 CFR Part 820/QMSR), ISO 13485, MDSAP, EU MDR 2017/745, UK MDR, Health Canada, and other international standards. The VP of QA/RA serves as the organization’s Management Representative and oversees regulatory strategy, quality operations, compliance governance, and audit readiness across all markets where AirStrip products are developed, marketed, and distributed. This role is accountable for ensuring product safety, effectiveness, cybersecurity compliance, and regulatory approvals that enable continued commercialization and market expansion. This position offers the ability to working remotely within the United States, or in a hybrid capacity out of our office in San Antonio, TX.Responsibilities include, but are not limited to:Establish, Maintain, Audit and Continuously Improve of the Company’s Quality Management System (QMS), Regulatory and other elective Compliance Programs.Responsible for the overall leadership of QA/RA Department functions, budget and development.Working with Company’s Executive Team to align the QA/RA Department activities with the Company’s evolving business strategy needs.Coordinate, develop, implement and maintain QSDs in order to assure compliance of the Company’s Quality System with MDSAP, ISO 13485, 21 CFR Part 820 and any other standards and regulatory guidance and requirements related to SaMDs.Provide professional support and expertise during MDSAP, ISO and FDA Audits by acting as a Subject Matter Expert (SME) for QA/RA topics.Develop the Regulatory Strategies and the content of the Premarket Submissions and/or Premarket Approvals (PMAs).Supervise the development and revise as well as approve the completion of the Risk Management Files, Clinical Evaluation Files, and Engineering documentation for the Projects.Oversee the Post-Market Surveillance Activities and Reports along with the Supplier Management Processes and report during the Management Review meetingsAct as a member of the Management Review Board (MRB) in order to review and approve the Corrective Actions Preventative Actions (CAPAs) for the elimination or prevention of the occurrence of the Product and/or Process NonconformitiesEnsure the conformity of the MDSWs/SaMDs is appropriately checked, in accordance with the QMS before the MDSWs/SaMDs are released.Monitor and maintain all company’s certifications and registrations that apply to any area the Company determines are in its best interest.Proactively develop Regulatory Strategy for a very efficient compliance of the Company’s Products and QMS with the current FDA Regulations.Coordinate the review and update of the Company’s QMS according to the current FDA Quality System Regulations (QSR).Act as an independent reviewer during all phases of the development of the Design History Files (DHFs) as wells as Market ReleasesResponsible for leading all the activities required be the Medical Device Reporting (MDR), including, when require, the Recall Activities and Documentation.This position is designated as the Management Representative under 21 CFR 820.20(b)(3) and is responsible for coordination of Management Review.Ensuring the ongoing and proactive compliance strategy with European Conformity (CE) requirements under the Medical Device Regulation (MDR).Assume the role of the designated Person Responsible for Regulatory Compliance (PRRC) under the EU regulations.Act as an independent reviewer during all phases of the development of the Technical Files (TFs), as wells as Product Registration.Coordinate all the activities related to Risk Management and post Markey Surveillance under ISO 24971, respectively MDR.Responsible for leading all the activities required be the Medical Device Vigilance System (MDVS), including the development or review of the Vigilance Reports.(Australia compliance): ensuring proper handling and ongoing regulatory and quality maintenance of Ai