Vice President, Quality Assurance & Regulatory Affairs

About Nihon Kohden OrangeMedNihon Kohden OrangeMed is a focused medical device company specializing in the design, development, and manufacture of innovative respiratory care products. Based in Santa Ana, California, our team works closely across engineering, manufacturing, quality, regulatory, and commercial functions to bring clinically meaningful ventilation technologies to healthcare providers and patients.As part of Nihon Kohden, a global leader in medical technology, OrangeMed offers a unique environment: the visibility, agility, and direct impact of a close-knit operating company combined with the resources and worldwide reach of an established global organization. The OpportunityWe are seeking a Vice President of Quality Assurance and Regulatory Affairs to serve as OrangeMed’s senior quality and regulatory leader and a key member of the leadership team.This is a hands-on executive role within a medical device manufacturing environment. The VP will establish quality and regulatory strategy while remaining actively engaged in the work, including complex quality investigations, regulatory decisions, manufacturing and supplier issues, product changes, audits, submissions, and team development.The ideal candidate combines strategic leadership with strong technical depth and enjoys working closely with the people designing, building, and supporting medical devices. What You Will DoLead OrangeMed’s Quality Assurance, Quality Control, and Regulatory Affairs functions.Serve as a trusted advisor to senior leadership on product quality, regulatory strategy, compliance, patient safety, and business risk.Maintain and continually improve the Quality Management System in accordance with FDA’s Quality Management System Regulation under 21 CFR Part 820, ISO 13485:2016, and other applicable requirements.Provide direct quality leadership across design and development, design transfer, manufacturing, supplier management, inspection, distribution, servicing, and post-market activities.Oversee CAPA, nonconformances, deviations, complaints, change control, document control, supplier quality, audits, and post-market surveillance.Establish regulatory strategies for new products, product changes, manufacturing changes, and domestic and international market expansion.Lead or oversee FDA premarket submissions, product registrations, regulatory reporting, labeling compliance, and post-market obligations.Serve as a primary contact for the FDA, notified bodies, certification organizations, customers, and other regulatory authorities.Maintain organizational readiness for regulatory inspections, notified-body audits, certification audits, and customer audits.Lead responses to audit findings, regulatory inquiries, product quality issues, field actions, and recalls when needed.Partner closely with Engineering, Manufacturing, Operations, Clinical, Service, Sales, and Marketing to incorporate quality and regulatory requirements into business and product decisions.Build, develop, and lead a capable QA/RA team while fostering accountability, collaboration, and continuous improvement.Establish meaningful quality objectives, metrics, and management-review processes that support product quality and business performance. What You BringBachelor’s degree in engineering, life sciences, quality, regulatory affairs, or a related technical discipline.At least 8 years of progressive quality assurance experience and at least 5 years of regulatory affairs experience within the medical device industry or another highly regulated industry.At least five years of people leadership experience, including responsibility for professional-level employees and/or managers.Demonstrated experience leading both Quality Assurance and Regulatory Affairs responsibilities in a medical device manufacturing environment.Strong working knowledge of FDA’s Quality Management System Regulation under 21 CFR Part 820, ISO 13485:2016, and applicable medical device regulations.Experience supporting Class I and Class II medical devices throughout the product lifecycle.Direct experience with FDA premarket submissions, including 510(k)s, and other applicable regulatory pathways.Experience leading FDA inspections, notified-body or certification audits, customer audits, and related corrective-action responses.Strong experience with CAPA, complaints, nonconformances, supplier quality, change control, document control, risk management, and post-market surveillance.Demonstrated ability to evaluate complex quality and regulatory issues and provide practical, risk-based recommendations.A leadership style that is collaborative, accountable, and comfortable operating both strategically and hands-on.Strong executive communication, business judgment, and decision-making skills. Preferred QualificationsMaster’s degree in engineering, life sciences, quality, regulatory affairs, or a related discipline.Experience supporting products in both U.S. and international markets.Working knowledge of EU MDR, CE marking, and Health Canada requirements.Experience strengthening or transforming a Quality Management System during business growth, organizational change, or evolving regulatory requirements.RAC, ASQ Certified Quality Engineer, or another relevant professional certification. Why Join OrangeMed?This opportunity is well suited for a quality and regulatory leader who wants to have a visible and direct impact. You will work close to the products, the onsite manufacturing operations, and the teams responsible for bringing respiratory technology to market. You will also have the opportunity to influence the direction of the business while benefiting from the support and global reach of the Nihon Kohden organization. Compensation: The anticipated base salary range for this position is $190,000 to $230,000. Actual compensation will be based on relevant experience, qualifications, internal equity, and other job-related considerations. Work Environment: This position is based on site in Santa Ana, California and includes regular interaction with employees in office, manufacturing, warehouse, laboratory, and inspection areas. Domestic and international travel of up to 15% may be required.