Manager- Post Market Surveillance (Recall)

CooperSurgical is a company focused on healthcare solutions, and they are seeking a Manager for Post Market Surveillance Recall activities. This role involves managing global Recall activities, preparing Health Hazard Evaluations, and collaborating with various stakeholders to ensure compliance with regulatory requirements.

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
• Ensure Recall procedures and processes are compliant with all applicable global regulations
• Stays apprised of latest developments in the global regulatory landscape related to Recalls
• Manages, develops and mentors Recall team, creating an atmosphere of encouragement, motivation, and growth opportunity
• Performs other duties as assigned

Requirements:

• Knowledge and ability to lead Recalls from initiation to closure in a medical device or pharmaceutical organization
• Excellent analytical, written and verbal skills, including strong presentation skills
• Ability to communicate with and influence various stakeholders at all organizational levels
• Ability to balance multiple projects/tasks, with a high degree of initiative and flexibility to adapt in changing environments
• Expert knowledge of FDA regulation 21 CFR 806, working knowledge of 21 CFR 803, 805, 806, 820 and ISO standards 13485, 14971, and EU MDR 2017/745, MDCG 2023-3
• Understanding of Quality Management Systems and the associated interrelationship with Recall process
• Ability to work efficiently in an e-QMS and incorporate technology (e.g., Artificial Intelligence tools) into the Recall process
• Ability to work within a global organization/team
• 4+ years leading HHEs and Recall decisions/Recall strategy
• Experience writing Recall communications
• Experience presenting as Recall owner in audits/inspections
• 5+ years of Quality Management Systems experience
• Bachelor's degree in Biomedical Science, Engineering or a related field
• Experience in Risk Management preferred