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
We offer a competitive salary, commensurate with experience, along with a comprehensive benefits package, including 401(k) Plan.
