Job Description

Job Location: Atlanta, GA 30313
Position Type: Full Time
Job Shift: AnyThe 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:
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- - - - 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.
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- Investigation Oversight and Quality
- - Ensure investigations are:
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- - - - 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.
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- Inspection Readiness
- - Ensure the complaint handling system is inspection-ready at all times, including:
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- - - - 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.
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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