Global Senior Manager, Post-Market Surveillance

Vero Biotech; Atlanta (GA); On-site; USD 140,000 - 200,000; Full time

Job summary

Vero Biotech is seeking a Senior Manager for Post-market Surveillance to lead the global complaint handling system across two sites. You will own intake, triage, investigation, and reporting, ensuring FDA and global regulatory compliance while driving risk-based decision-making and inspection readiness.

The role requires 8+ years in Quality/Regulatory functions in medical devices or combination products, plus 3+ years in leadership within post-market activities.

Qualifications

• 8+ years in Quality/Regulatory roles in medical device, pharmaceutical, or combination products.
• 3+ years of leadership experience in complaint handling or Post-Market Surveillance.
• Excellent communication and leadership skills with the ability to influence senior stakeholders.
• Ability to manage multiple priorities and drive execution in a fast-paced environment.

Responsibilities

• Own end-to-end complaint lifecycle across two sites, ensuring consistent execution and harmonization.
• Define and maintain a single global complaint process with clearly delineated site responsibilities (intake, triage, investigation, closure).
• Establish and maintain a site ownership model (product vs investigation vs reporting).
• Ensure appropriate escalation pathways for cross-site complaints and systemic issues.
• Lead development and maintenance of combination product complaint decision trees and reportability algorithms.
• Oversee regulatory reporting including MDRs and other global vigilance reports; ensure defensible decisions.
• Coordinate integration of pharmacovigilance, device vigilance, and quality systems into a unified surveillance process.
• Maintain inspection readiness with complete documentation and traceability.

Skills

Leadership

Communication

Regulatory knowledge

Project management

Education

Bachelor’s degree in engineering, Life Sciences, or related field; master’s preferred

Job description

Vero Biotech is seeking a Senior Manager for Post-market Surveillance to lead the global complaint handling system across two sites. You will own intake, triage, investigation, and reporting, ensuring FDA and global regulatory compliance while driving risk-based decision-making and inspection readiness.

The role requires 8+ years in Quality/Regulatory functions in medical devices or combination products, plus 3+ years in leadership within post-market activities.