Vice President of Quality Assurance

Job Summary

A company is looking for a Vice President of Quality Assurance and Regulatory Affairs.

Key Responsibilities

• Establish, maintain, audit, and continuously improve the Quality Management System (QMS) and compliance programs
• Lead the QA/RA Department functions, budget, and development while aligning activities with the company's business strategy
• Oversee regulatory strategy, quality operations, and ensure product safety and compliance with applicable regulations

Required Qualifications

• Extensive experience in Quality Assurance and Regulatory Affairs, particularly in Software-as-a-Medical-Device (SaMD)
• Knowledge of FDA Quality Management System Regulation, ISO 13485, MDSAP, and EU MDR standards
• Proven leadership skills in managing QA/RA departments and cross-functional teams
• Experience with regulatory submissions and post-market surveillance activities
• Ability to act as a Subject Matter Expert during audits and regulatory interactions