Senior Manager, Post-Market Surveillance

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.

• Complaint Handling System Ownership (Multi-Site) 
  • 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. 
• Combination Product Compliance 
  • 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. 
• Regulatory Reporting & Vigilance 
  • 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. 
• Investigation Oversight and Quality 
  • 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. 
• Inspection Readiness 
  • 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.

Qualifications

• 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.

Supervisory Responsibilities

• Expert knowledge of:
  • 21CFR 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

Competencies

• 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

Physical Demands and Work Environment

• Standard Office Environment
• Occasional travel may be required