Vice President, Quality Assurance & Regulatory Affairs | AirStrip

NantHealth•San Antonio, TX

3d•Remote

About The Position

AirStrip is seeking a Vice President, Quality Assurance and Regulatory Affairs (QA/RA) to lead our global quality and regulatory strategy for our growing Software-as-a-Medical-Device (SaMD) portfolio. This is a highly visible executive role responsible for shaping regulatory strategy, strengthening external partnerships, and ensuring the organization maintains a scalable, efficient, and compliant quality infrastructure that supports innovation and growth. The Vice President will serve as the organization’s Management Representative, providing executive-level governance across quality operations, regulatory strategy, and compliance. The ideal candidate is both strategic and pragmatic leader who can build trusted relationships with regulators and stakeholders while ensuring the organization operates with confidence, consistency, and operational discipline. 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. What Success Looks Like This role is intentionally structured to balance strategic leadership with strong internal governance. Approximately 75% of the role is dedicated to strategic and external-facing leadership, including regulatory engagement, industry representation, and long-term regulatory planning. The remaining focus centers on executive oversight of internal quality systems, compliance readiness, and organizational governance. Success in this role will be measured by: Strong and sustainable regulatory relationships Consistent audit readiness and successful inspections Scalable, efficient quality processes that support growth Reduced regulatory risk and improved speed to market Readiness for new product launches and geographic expansion

Requirements

Bachelor’s degree in a scientific, engineering, clinical, or related discipline (advanced degree preferred)
10+ years of progressive leadership experience in Quality Assurance and Regulatory Affairs within medical devices and/or SaMD
Demonstrated experience working directly with FDA and global regulatory agencies
Proven track record leading successful regulatory inspections and audits
Deep working knowledge of quality management systems and regulatory compliance frameworks
Experience developing regulatory strategy and guiding global submissions and approvals
Ability to effectively lead and manage, coach and mentor a team
Business Awareness – Knows what AirStrip does and how AirStrip does it. Is aware of competitors. Up-to-date with general business and regularity news. Aware of developments in the sector. Thinks about regularity implications. Understands the importance of customer satisfaction and shareholder value.
Analysis/Problem Solving – Able to identify and separate out the key components of problems and situations. Can generate a range of creative solutions, evaluate them and choose the most appropriate option.
Teamwork – Actively participates in teams. Encourages co-operation. Aware of the needs of others and responds flexibly. Prioritizes team goals over individual goals.
Communication – Able to communicate information and ideas clearly and articulately both in oral and written form. Uses appropriate language, style and methods depending on audience and the purpose of communication.
Self Confidence/Resilience – Measured confidence to take on demanding work or put forward views when they may be challenged. Stays calm in a crisis. Handles competing demands. Overcomes setbacks. Welcomes and learns from criticism.
Judgement/Decision Making – Takes balanced view of situations incorporating different perspectives. Seeks alternative viewpoints. Recognizes priorities, weighs up different options and evaluates risks.
Researching And Investigating – Has the ability to recognize information needs and identify and utilize appropriate information sources. Persists in seeking information and adopts a variety of strategies. Questions, checks and evaluates information and sources. Pays attention to details.
Planning And Organizing – Able to achieve results in a quality, timely, and cost-effective way. Sees priorities, plans the efficient use of resources, and monitors progress against objectives. Anticipates crucial stages in projects. Formulates alternative means of achieving objectives. Responds effectively to unforeseen events.

Nice To Haves

advanced degree preferred

Responsibilities

Own and evolve AirStrip’s global regulatory strategy aligned to business goals and product roadmap
Build and maintain strong relationships with regulatory agencies and industry stakeholders
Represent AirStrip externally through regulatory engagement, industry participation, and strategic partnerships
Monitor regulatory trends and translate them into proactive, actionable plans
Provide strategic direction for global submissions, approvals, and market expansion
Lead the continued development and continuous improvement of AirStrip’s Quality Management System (QMS)
Ensure quality processes are scalable, efficient, and aligned with organizational growth
Maintain consistent readiness for regulatory inspections and audits (e.g., FDA, ISO, MDSAP)
Provide executive oversight of risk management, quality performance, and compliance programs
Lead Management Review activities and ensure appropriate escalation and resolution of quality and compliance risks
Lead, coach, and develop a high-performing QA/RA organization
Set clear expectations, accountability, and development pathways for team members
Partner closely with Engineering, Product, Clinical, Security/Privacy, and Legal teams to embed quality and regulatory requirements into development and operations
Model a practical, solutions-oriented leadership style in a collaborative, fast-moving environment
Ensure alignment with global regulatory and quality requirements, including: FDA Quality Management System Regulation (21 CFR Part 820), ISO 13485, MDSAP, EU MDR and other international regulatory frameworks