Vice President, Quality Assurance and Regulatory Affairs - Sarnova - Dallas, TX

Sarnova HC, LLC

Position Title: Vice President, Quality Assurance and Regulatory Affairs
- Sarnova
- Dallas, TX

Sarnova is the leading national specialty distributor of health care products in Emergency Medical Services (EMS) and Respiratory Markets and is the industry leader in Revenue Cycle Management within Emergency Medical Services (EMS). The company operates through several market-leading companies including Tri-anim Health Services, the largest specialty distributor of respiratory products, Bound Tree Medical, the largest supplier of EMS products, and Cardio Partners, a full Sudden Cardiac Arrest Solution provider, and Digitech, the leader in EMS revenue cycle management.

Sarnova is seeking a Vice President, Quality Assurance and Regulatory Affairs to lead the company’s quality and regulatory strategy as it expands from a specialty medical products distributor into medical device manufacturing. This executive will build and mature the company’s quality systems, regulatory affairs capabilities, audit readiness, manufacturing quality, supplier quality, and post-market surveillance across manufactured, private-label, and acquired product portfolios.

The ideal candidate will be a hands-on strategic leader with deep medical device QMS and regulatory experience, strong business judgment, experience integrating acquired operations, and the ability to build a scalable quality culture that supports growth while protecting patients, customers, and the company.

The Vice President, Quality Assurance and Regulatory Affairs is responsible for establishing and leading the quality and regulatory framework that supports Sarnova’s growth into medical device manufacturing. This role has significant impact on patient safety, regulatory compliance, product quality, operational excellence, and enterprise risk management. By ensuring effective quality systems, regulatory readiness, and a strong culture of compliance, this leader enables successful product commercialization, acquisition integration, and sustainable business growth while protecting the company's reputation and market position.

• Lead the enterprise Quality Assurance and Regulatory Affairs function, ensuring quality, and patient safety support business objectives and growth.
• Develop, implement, and maintain an effective Quality Management System (QMS) aligned with FDA, ISO 13485, MDSAP, and other applicable regulatory requirements.
• Serve as Sarnova’s primary quality and regulatory representative with regulators, auditors, customers, suppliers, and strategic partners.
• Lead manufacturing quality programs, including production controls, process validation, CAPA, complaint handling, supplier quality, and inspection processes.
• Develop and execute regulatory strategies for product approvals, registrations, market access, labeling compliance, and lifecycle management.
• Partner with Product Development, Operations, Supply Chain, Marketing, Commercial, Sustainability and Legal teams to integrate quality and regulatory requirements throughout the product lifecycle.
• Oversee design quality, design controls, risk management, verification and validation activities, and product transfer to manufacturing.
• Direct post-market surveillance activities, including complaints, adverse event reporting, field actions, recalls, and product risk monitoring.
• Establish and manage supplier quality programs, including supplier qualification, audits, performance monitoring, and corrective actions.
• Support acquisition due diligence, integration, and remediation activities related to quality and regulatory compliance.
• Build and develop a high-performing quality and regulatory organization, including…