Post Market Surveillance Manager

The Manager, Post Market Surveillance- Recall is responsible for CooperSurgical, Inc.’s (CSI) global Post Market Surveillance Recall activities, working with various internal/external stakeholders, and managing the Recall team.  This position is responsible for managing CooperSurgical’s global Recall activities, including but not limited to preparation of Health Hazard Evaluations (HHEs), executing Corrections and Removals, interacting with regulatory authorities, and identifying continuous improvement opportunities in the Recall process and implementing updates. Responsible for managing and mentoring members of CSI’s Recall team. 

Responsibilities

• Leads CSI Recall process for assessment & execution of corrections and removal of a wide variety of medical products (e.g., medical devices, IVDs).

• Responsible for all aspects of CSI’s Recall process, including but not limited to preparation of required regulatory documentation and internal/external communications related to Recalls (e.g., Health Hazard Evaluation, Recall Execution Strategy, Field Safety Communications, Recall Termination Requests).

• Manages Health Hazard Evaluations from initiation through completion, leading cross-functional teams through process, ensuring timely completion.  

• Collaborates closely with leadership in Quality & Medical Affairs on the development/approval of HHEs.

• Provides direction/guidance to Recall team on execution of Recalls with customers, distributors, and regional RAQA representatives.

• Leads all Recall reporting activities (including 806/FSCA reports) to US FDA, EU Competent Authorities and other Health Authorities globally, as needed. Maintains active communication with CSI’s Authorized Representative(s) and Notified Body, as required.

• Ensures reporting requirements are compliant with CSI Policy in accordance with applicable global laws & regulations. 

• Collaborates closely with CSI cross-functional leaders across various Business Units & Global Markets.

• Resolves Regulatory Agency/Health Authority requests in relation to reportable Corrections and Removals, ensuring timely closure/termination. 

• Maintains and monitors HHE/Recall Key Performance Indicators (KPI), escalating and reporting progress to CSI Leadership on HHEs/Recalls as appropriate/required per local QMS procedures.

• Establishes and maintains department metrics that complement CSI goals, targets, and objectives.

• Assesses and identifies process improvements, developing and implementing business solutions related to Recall process.

• Serves as CSI’s Recall Process Owner and Subject Matter Expert, leading all front room Recall interactions during Notified Body MDSAP audits/FDA inspections.