Senior Manager, Post-Market Surveillance

Job Details

Job Location:

Atlanta, GA 30313

Position Type:
Full Time

Job Shift: Any

The Senior Manager, Post-market Surveillance is responsible for the strategic leadership, governance, and continuous improvement of the Post-market Surveillance system for Vero Biotech’s combination product portfolio. This role has end-to-end ownership of the complaint handling process, including intake, triage, investigation, and regulatory reporting, across a two-site operating model. The position ensures compliance with applicable FDA regulations (21 CFR Parts 4, 803, 820, and 210/211 as applicable) and international standards, while driving consistency, inspection readiness, and risk-based decision-making across both sites.

• Own and oversee the end-to-end complaint lifecycle across both manufacturing/operational sites, ensuring consistent execution and harmonization.
• Define and maintain a single global complaint process with clearly delineated site responsibilities, including:
  • Intake and logging
  • Triage and reportability assessment
  • Investigation ownership and execution
  • Closure and trending
• Establish and maintain a site ownership model (e.g., product ownership vs. investigation ownership vs. reporting accountability).
• Ensure appropriate escalation pathways for cross-site complaints and systemic issues.

• Ensure complaint handling meets requirements for both device and drug constituent parts, including:
  • Device complaint requirements (21 CFR 820.198)
  • MDR reporting (21 CFR 803)
  • Field alert reporting/drug product considerations, as applicable
• Lead development and maintenance of combination product complaint decision trees and reportability algorithms.
• Ensure integration of pharmacovigilance, device vigilance, and quality systems into a unified surveillance process.

• Oversee timely, accurate, and compliant submission of:
  • Medical Device Reports (MDRs)
  • Corrections and removals (21 CFR 806)
  • Other applicable global vigilance reports
• Serve as the SME for reportability determinations, ensuring defensible, well-documented decisions.

• Ensure investigations are:
  • Scientifically sound
  • Risk-based
  • Root-cause driven
  • Completed within established timelines
• Define requirements for cross-site investigations, including when joint investigations are required.
• Ensure alignment with CAPA, nonconformance, and signal detection processes.

• Ensure the complaint handling system is inspection-ready at all times, including:
  • Complete documentation
  • Traceability from complaint → investigation → CAPA → closure
  • Clear rationale for reportability decisions
  • Lead preparation and defense of complaint data during FDA inspections and internal audits.

• Bachelor’s degree in engineering, Life Sciences, or related field (master’s preferred)
• 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.

• Expert knowledge of:
  • 21
    
    CFR 820, 806, 806
  • 21 CFR 210/211
  • 21 CFR Part 4
• Cross-functional leadership and influence
• Data-driven decision-making and analytical thinking
• Strong organizational and prioritization skills
• Effective communication across all levels of the organization
• Ability to operate in ambiguity and drive structure

• Lead and develop a team responsible for complaint intake, investigation, and regulatory reporting activities
• Define roles, responsibilities, and performance expectations for complaint handling personnel across both sites
• Conduct hiring, onboarding, training, performance reviews, and succession planning
• Allocate resources across sites to ensure balanced workload and timely complaint processing
• Ensure clear delineation of site responsibilities (e.g., intake vs. investigation vs. reporting) while maintaining a unified process
• Resolve cross-site conflicts and escalations related to ownership, priorities, or decision-making

• Standard Office Environment
• Occasional travel may be required