Post Market Surveillance Manager (Medical Devices)

Responsibilities

• Establish an efficient global audit program for compliance and quality systems
• Harmonize audit processes across the organization to meet regulatory requirements
• Manage compliance with eMDR and Vigilance reporting for the PMS program
• Facilitate the development of a skilled team of internal auditors
• Maintain comprehensive logs of audits, findings, and follow-up actions
• Conduct proactive data analysis to identify opportunities for system improvements
• Ensure timely reporting of key metrics on a global dashboard

Qualifications

• 4-5 years of experience in post-market surveillance and quality assurance for medical devices
• Experience with FDA reporting and compliance specific to medical devices
• Bachelor's degree in a relevant field
• Proven ability to manage and maintain quality audit programs
• Experience leading teams and facilitating collaboration among auditors

Benefits

• Remote work opportunity within the United States
• Chance to lead global quality assurance initiatives
• Access to industry best practices and continuous improvement initiatives
• Opportunity to influence compliance standards and practices across a major medical devices organization