Senior Manager, Post-Market Surveillance

About the Role

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.

Responsibilities

• 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.
• Supervisory Responsibilities
  • 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.

Requirements

• 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.
• Expert knowledge of:
  • 21 CFR 820, 806, 803
  • 21 CFR 210/211
  • 21 CFR Part 4

Skills

• 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.
• 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.

Work Environment

• Standard office environment.
• Occasional travel may be required.