Post Market Surveillance Manager

Job Summary

The full-time remote Post Market Surveillance Regulatory Manager will establish and manage a global program for auditing quality systems and compliance, focusing on FDA reporting and medical device regulations while empowering teams to enhance outcomes.

Key responsibilities

• Manage the Owens & Minor Global QARAC Audit program to ensure compliance with customer and regulatory requirements
• Oversee the Global Post Market Surveillance program, ensuring adherence to eMDR and Vigilance reporting standards
• Conduct proactive data analysis to identify opportunities for continuous improvement in quality and compliance systems

Required qualifications

• Bachelor's Degree
• Minimum 4-5 years of experience in quality assurance and regulatory compliance, specifically with medical devices
• Experience with FDA reporting and compliance
• Proven ability to manage a team of auditors
• Strong understanding of quality system audit processes and best practices