Senior Manager, Post-Market Surveillance

Job DetailsJob Location: Atlanta, GA 30313Position Type: Full TimeJob 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: 



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