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.

• 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