Vice President, Quality Assurance and Regulatory Affairs - Sarnova - Dublin, Ohio

Sarnova; Dublin (OH); On-site; USD 180,000 - 280,000; Full time

Benefits offered by this job

401(k) Plan

Job summary

Sarnova is seeking a Vice President of Quality Assurance and Regulatory Affairs to lead the company’s quality and regulatory strategy as it expands into medical device manufacturing. This executive will build a scalable QMS, regulatory capabilities, and audit readiness across product portfolios and acquisitions.

The role requires deep medical device QMS and regulatory experience, strong business judgment, and the ability to integrate operations while protecting patients and the company’s

Qualifications

• Bachelor’s degree in a technical field required; advanced degree preferred.
• 15+ years in quality assurance/regulatory affairs in regulated manufacturing.
• 7+ years leading quality/regulatory functions.
• Extensive knowledge of FDA, ISO 13485, CAPA, audits, post-market surveillance.
• Experience with 510(k) submissions and international regulatory requirements.
• Experience integrating acquisitions and building scalable QMS.

Responsibilities

• Lead the enterprise QA and Regulatory Affairs function to support growth.
• Develop and maintain QMS aligned with FDA/ISO13485/MDSAP and regulatory requirements.
• Serve as primary QA/regulatory representative with regulators, auditors, customers, and partners.
• Lead manufacturing quality programs: production controls, process validation, CAPA, supplier quality.
• Develop regulatory strategies for product approvals, registrations, and lifecycle management.
• Partner with cross-functional teams to integrate quality and regulatory requirements.

Skills

Strategic leadership

Regulatory affairs

Quality management

FDA/ISO knowledge

Stakeholder management

Education

Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, Quality

Advanced degree preferred

Job description

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.

Summary

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.

Organizational Impact

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.

Essential Duties And Responsibilities

• 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 talent development, succession planning, budgeting, and performance management.
• Develop quality metrics, drive continuous improvement initiatives, and foster a culture of quality, accountability, and regulatory excellence.
• Perform other duties as assigned.

Skills/Experience Required

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or a related technical discipline required; advanced degree preferred
• 15+ years of combined experience in quality assurance and regulatory affairs within the medical device or other regulated manufacturing environments
• 7+ years of progressive leadership experience leading quality and regulatory functions
• Extensive knowledge of FDA regulations, ISO 13485, design controls, CAPA, supplier quality, audit management, and post-market surveillance
• Experience managing regulatory submissions and product registrations, including 510(k) and international regulatory requirements
• Proven success leading regulatory inspections, audits, and remediation initiatives
• Experience supporting manufacturing, private-label, sourced, distributed, or contract-manufactured product portfolios
• Experience with acquisition due diligence, integration, and quality system harmonization preferred
• Strong strategic leadership, business partnership, and executive influencing skills
• Demonstrated ability to build scalable quality systems, develop teams, and drive organizational change
• Excellent analytical, communication, and stakeholder management skills

Sarnova is an Equal Opportunity Employer. We offer a competitive salary, commensurate with experience, along with a comprehensive benefits package, including 401(k) Plan. EEO/M/F/Veterans/Disabled. Our mission is to be the best partner for those who save and improve patients’ lives. Excellence in delivering upon our mission is dependent upon having a diverse team that is empowered to bring their full, authentic self to work each day. We strive to create a workplace that reflects the communities we serve, and we are passionate about creating an inclusive workplace that promotes and values diversity.