Post Market Surveillance Manager (Medical Devices)

📋 Description

• Lead global PMS programs aligned with regulatory requirements
• Ensure FDA reporting, eMDR, and vigilance processes
• Develop and improve quality/compliance audits across operations
• Manage audit planning, execution, tracking, and follow‑up
• Coordinate internal auditors and centralized audit records
• Monitor audit findings and implement corrective actions

🎯 Requirements

• Bachelor’s degree in a relevant field
• 4+ years in quality assurance, regulatory affairs, PMS, or related medical device functions
• Experience managing FDA reporting and compliance for medical devices
• Strong knowledge of medical device regulations, quality systems, audit processes
• Experience developing/managing PMS programs and regulatory reporting
• Experience leading teams in quality, compliance, or regulatory environments

🎁 Benefits

• Competitive annual salary range of $100,000 - $118,000 USD
• Fully remote work opportunity within the United States
• Comprehensive healthcare coverage including medical, dental, vision
• Employer‑paid life insurance and disability coverage
• 401(k) and HSA options
• Supplemental insurance programs including hospitalization and critical illness