Senior Manager, Post-Market Surveillance

VERO BIOTECH INC•Atlanta, GA

7d•Onsite

About The Position

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.

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
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: 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

Responsibilities

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.
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.