About this role

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

Source listing: virtualvocations_main