Sr Manager Post Market Surveillance

Sr Manager Post Market Surveillance

The Senior Manager, Post Market Surveillance provides strategic and operational leadership for the Global Post Market Surveillance (PMS) function. This role is responsible for leading and continuously improving the processes, systems, and team capabilities that support complaint handling, product performance monitoring, adverse event/vigilance reporting, recalls, trend analysis, and post-market regulatory compliance. The Senior Manager partners cross-functionally with Regulatory Affairs, Quality, Clinical Affairs, R&D, Manufacturing, Customer Service, and Commercial teams to ensure timely identification, assessment, escalation, and communication of product performance issues. This leader drives a culture of compliance, data-driven decision-making, continuous improvement, and customer focus while ensuring that PMS activities meet applicable global regulatory requirements and internal quality standards.
Leadership and Strategy
Lead the Global Post Market Surveillance function, including team direction, prioritization, performance management, and capability development.
Establish and execute PMS strategies, goals, and priorities that align with organizational and regulatory requirements.
Provide leadership for the continued development, standardization, and optimization of PMS processes, procedures, systems, and metrics.
Build and maintain a high-performing team with strong technical expertise, accountability, and collaboration.
Post-Market Surveillance Operations
Oversee timely and compliant intake, triage, investigation, documentation, and closure of product complaints.
Ensure appropriate evaluation of product performance data, adverse events, and other post-market signals to identify trends, emerging risks, and opportunities for improvement.
Direct complex complaint investigations, including serious incidents, escalating issues, and potential field actions or recalls, as applicable.
Ensure robust monitoring of complaint and product performance data to support proactive issue detection and signal management.
Regulatory Compliance and Reporting
Ensure compliance with applicable global post-market surveillance, vigilance, and adverse event reporting requirements.
Oversee preparation, review, and submission of reportable events to regulatory authorities within required timelines.
Provide leadership and oversight for post-market regulatory deliverables, including PMS plans, PMS reports, Periodic Safety Update Reports (PSURs), and other required post-market documentation, as applicable.
Maintain awareness of evolving global regulations, standards, and industry expectations related to PMS and incorporate changes into processes and training.
Risk Management and Escalation
Lead the Post market risk management board (RMB)
Ensure product performance issues are appropriately assessed for potential safety, clinical, quality, and regulatory impact.
Lead cross-functional escalation and decision-making for significant post-market issues, including regulatory reporting, field actions, customer communications, and risk mitigation.
Support management review and quality review forums with meaningful PMS insights, trends, and recommendations.
Cross-Functional Collaboration
Partner with Regulatory Affairs, Quality Assurance, Clinical Affairs, R&D, Manufacturing, and Commercial teams to investigate issues and implement corrective and preventive actions.
Collaborate with internal stakeholders to develop customer and regulatory communications related to product performance or post-market issues.
Serve as a subject matter expert for post-market surveillance requirements, complaint handling, vigilance, and related business processes.
Analytics and Continuous Improvement
Drive the use of metrics, trend analysis, dashboards, and other data tools to enhance visibility into product performance and process effectiveness.
Identify and implement process improvements that increase compliance, efficiency, quality, and responsiveness.
Use post-market insights to inform broader product quality, design, and customer experience improvements.
Education & Work Requirements
Bachelor's Degree with 12-15 years of related experience
Bachelor's degree in Nursing, Life Sciences, or related healthcare field required (e.g., RN, BSN, or equivalent clinical background preferred.)
About Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.