Vice President, Quality Assurance & Regulatory Affairs

Job overview

Vice President, Quality Assurance & Regulatory Affairs is an onsite role in Santa Ana, CA, primarily in office and manufacturing settings. The annual base salary range is $190,000–$230,000. The executive leads quality and regulatory functions for a medical device company and serves as its senior quality and regulatory authority. The role establishes quality and regulatory strategy, maintains an effective quality management system, and supports compliance across products and markets. It advises senior leadership, leads the QA/RA organization, and works across functions to manage product quality, regulatory risk, audits, and market requirements.

What you'll do

• Lead Quality Assurance, Quality Control, and Regulatory Affairs strategy and teams
• oversee the quality management system and continuous improvement
• manage audits, CAPA, nonconformances, complaints, and corrective actions
• establish regulatory strategies for current and new products and markets
• serve as primary executive contact for FDA and other authorities
• oversee post-market surveillance, adverse-event reporting, product risk, and recalls
• advise senior leaders and partner cross-functionally on quality and regulatory matters.

What we're looking for

Skills & competencies

vice president

quality assurance

regulatory affairs

medical devices

quality management system

fda compliance

iso 13485

capa

santa ana ca

nihon kohden orange med

$190k–$230k

Work arrangement

• Weekend coverage required

Why this role

Executive leadership of an approximately 25-person QA/RA organization in a medical device manufacturing environment; domestic and international travel may be required periodically.

About the employer

Nihon Kohden Orange Med is hiring for this role. Industry: Electromedical and Electrotherapeutic Apparatus Manufacturing. Sector: 33.