Product Surveillance Senior Supervisor

CooperCompanies•North Tonawanda, NY

1d•Onsite

About The Position

The Product Surveillance Sr. Supervisor is responsible for providing strategic oversight and leadership of post‑market surveillance and product complaint investigation activities for combination drug‑device products in compliance with applicable U.S. and international regulatory requirements, including 21 CFR Parts 210, 211, 820, and ISO 13485. This role ensures the consistent, compliant, and scientifically sound execution of risk‑based complaint investigations through effective application of investigation methodologies, root cause analysis, and risk assessment principles, and has accountability for investigation quality, prioritization, escalation decisions, and inspection readiness, while driving cross‑functional alignment and continuous improvement of the Product Surveillance function in support of product safety, regulatory compliance, and patient protection.

Requirements

Advanced expertise in overseeing comprehensive, risk‑based product complaint investigations, including application of structured root cause analysis methodologies and evaluation of investigation quality for combination drug‑device products.
Strong risk assessment and decision‑making skills, with the ability to interpret investigation data, assess patient safety and regulatory risk, and determine appropriate escalation pathways, including CAPA initiation, Health Hazard Evaluations, trend analysis, and regulatory reporting.
Proven ability to review, approve, and defend complaint investigations and escalation decisions, ensuring scientific rigor, regulatory compliance, and alignment with business and patient safety objectives.
Excellent leadership and supervisory skills, including the ability to coach, mentor, and provide technical guidance to Product Surveillance personnel to ensure consistent investigation practices and regulatory compliance.
Highly effective cross‑functional communication and facilitation skills, enabling collaboration with Quality, Regulatory Affairs, R&D, Manufacturing, Medical Affairs, Supply Chain, and external partners to drive timely complaint resolution and risk mitigation.
Strong analytical and problem‑solving capabilities, with the ability to evaluate trends, identify emerging post‑market risk signals, and recommend proactive quality and system improvements.
Demonstrated proficiency in maintaining and overseeing controlled complaint and post‑market surveillance records, databases, and tracking tools to ensure accuracy, traceability, and inspection readiness.
Exceptional written communication skills, including the ability to ensure complaint investigations, risk assessments, and regulatory justifications are clear, objective, contemporaneous, and audit‑defensible.
Strong organizational and prioritization skills, with the ability to manage investigation workload, monitor action item status, and drive timely follow‑up and escalation across multiple stakeholders.
In‑depth understanding of audit and inspection dynamics, with the ability to serve as a subject‑matter expert during internal and external audits related to complaint handling, post‑market surveillance, CAPA, and regulatory compliance.
Continuous improvement mindset, with the ability to use investigation outcomes, trending data, and regulatory expectations to enhance post‑market surveillance and Quality Management System processes and tools.
5+ years of experience in the pharmaceutical, medical device, or combination product industry, with demonstrated responsibility for product complaint handling, post‑market surveillance, CAPA processes, and regulatory compliance within a regulated environment.
2+ years of oversight of complaint investigation activities, mentoring and coaching technical staff, workload prioritization, and accountability for investigation quality, timelines, and escalation decisions.
Bachelor’s degree in a Health, Engineering or Science field required.

Responsibilities

Provides strategic oversight of comprehensive, risk‑based product complaint investigations for combination drug‑device products, ensuring consistent application of appropriate investigation methodologies and root cause analysis tools across the Product Surveillance function.
Reviews, triages, and assigns incoming product complaints to ensure investigations are prioritized appropriately and conducted in a timely, scientifically sound, and compliant manner, with thorough assessment of product performance, patient safety impact, and regulatory risk.
Evaluates and approves investigation outcomes, including documented risk assessments, to determine the need for escalation such as CAPA initiation, Health Hazard Evaluations, trend analysis, and regulatory reporting, ensuring potential risks are accurately identified, justified, and effectively addressed.
Leads and facilitates cross‑functional meetings and decision‑making forums to drive complaint resolution, post‑market risk evaluation, and data alignment, partnering with Quality, Regulatory, R&D, Manufacturing, Medical Affairs, Supply Chain, and external parties such as contract manufacturers and suppliers.
Oversees verification of investigation conclusions and associated corrective and preventive actions through defined follow‑up activities, effectiveness checks, and milestone reviews, ensuring corrective actions address root causes and mitigate identified risks.
Coaches, mentors, and provides technical guidance to Product Surveillance personnel, promoting consistent investigation quality, regulatory compliance, and professional development across the team.
Reviews and approves product complaint investigations to ensure all investigation activities, root cause analyses, risk assessments, and follow‑up actions are completed in compliance with applicable regulatory requirements and internal procedures.
Ensures the maintenance of complete, accurate, and traceable complaint and post‑market surveillance records within designated tracking systems and databases; monitors investigation progress and action item status and drives timely escalation when required.
Ensures post‑market surveillance and complaint investigation documentation remains clear, objective, contemporaneous, and compliant, supporting inspection readiness, audit defensibility, and regulatory confidence.
Escalates and contributes to field actions, including field alerts and recalls, based on investigational findings, ensuring alignment with regulatory requirements and internal escalation processes.
Develops, reviews, and presents routine post‑market surveillance metrics, trending analyses, and risk signals to leadership to support oversight, decision‑making, and continuous improvement initiatives.
Serves as a subject‑matter expert during internal and external audits and inspections related to complaint handling, post‑market surveillance, complaint CAPA escalation, and regulatory compliance for combination products.
Drives continuous improvement of post‑market surveillance and Quality Management System processes, procedures, tools, and investigative practices based on complaint trends, investigation outcomes, risk signals, and evolving regulatory and industry expectations.
Perform other duties as assigned.