Product Surveillance Senior Supervisor

CooperCompanies•North Tonawanda, NY

12h•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

Compliance with applicable U.S. and international regulatory requirements, including 21 CFR Parts 210, 211, 820, and ISO 13485.
Effective application of investigation methodologies, root cause analysis, and risk assessment principles.
Accountability for investigation quality, prioritization, escalation decisions, and inspection readiness.
Cross-functional alignment and continuous improvement of the Product Surveillance function.
Timely, thorough, and compliant evaluation of post-market information.
Intake, review, triage, assignment, and approval of complaint investigations.
Evaluation of investigation outcomes to determine appropriate escalation actions.
CAPA initiation, Health Hazard Evaluations, trend analysis, regulatory reporting, and field actions such as recalls or field alerts.
Cross-functional collaboration with Quality, Regulatory Affairs, R&D, Manufacturing, Medical Affairs, Supply Chain, and external partners.
Verification of investigation conclusions and corrective actions.
Ensuring the integrity and traceability of complaint and post-market surveillance records.
Maintaining audit-ready documentation.
Coaching and mentoring Product Surveillance personnel.
Promoting consistent investigative practices.
Serving as a subject-matter expert during internal and external audits and inspections.
Developing and presenting routine post-market surveillance metrics and trending analysis to leadership.
Driving continuous improvement of post-market surveillance and Quality Management System processes.

Responsibilities

Oversees and directs comprehensive, risk-based product complaint investigations for combination drug-device products, ensuring timely, thorough, and compliant evaluation of post-market information.
Responsible for the intake, review, triage, assignment, and approval of complaint investigations.
Evaluates investigation outcomes to determine appropriate escalation actions, including CAPA initiation, Health Hazard Evaluations, trend analysis, regulatory reporting, and field actions such as recalls or field alerts.
Leads cross-functional collaboration with Quality, Regulatory Affairs, R&D, Manufacturing, Medical Affairs, Supply Chain, and external partners to drive effective complaint resolution, post-market risk evaluation, and data alignment.
Oversees verification of investigation conclusions and corrective actions, ensuring the integrity and traceability of complaint and post-market surveillance records.
Maintains audit-ready documentation.
Coaches and mentors Product Surveillance personnel, promotes consistent investigative practices.
Serves as a subject-matter expert during internal and external audits and inspections.
Develops and presents routine post-market surveillance metrics and trending analysis to leadership.
Drives continuous improvement of post-market surveillance and Quality Management System processes based on investigation outcomes, risk signals, and evolving regulatory expectations.