Vice President, Quality Assurance & Regulatory Affairs | AirStrip

Vice President, Quality Assurance and Regulatory Affairs (QA/RA)

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 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

Responsibilities include, but are not limited to:

Strategic & External Leadership

• 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

Quality Systems & Compliance Leadership

• 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

Team Leadership & Cross-Functional Partnership

• 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

Regulatory Scope (this role ensures 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

Education & Experience 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

Required Knowledge, Skills, and Abilities:

• 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.

The salary range for applicable US-based applicants to this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.

• $160,000 - $205,000 base salary plus bonus potential.

We value each of our employee's total wellness. From robust medical, dental, and vision insurance, to financial planning assistance, to physical and mental wellness discounts, and unlimited access to our online learning platform, we understand that our company succeeds when our employees succeed as individuals.

Additional notable US-employee benefits include:

• Paid Time Off (hourly) / Flex Time Off (salaried) programs for Full Time employees
• Growth and Development opportunities
• 401(k), including a 3% company match
• Paid Holidays
• Paid Parental Leave, including a flexible return-to-work program
• Employee Assistance Program
• Discounts on popular cell phone plan providers
• Life & Disability Insurance
• And more!

AirStrip provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.