[Hiring] Manager - Post Market Surveillance @CooperCompanies

Role Description

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
• Identifying continuous improvement opportunities in the Recall process and implementing updates
• Managing and mentoring members of CSI’s Recall team

Responsibilities include:

• Leading 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 preparation of required regulatory documentation and internal/external communications related to Recalls
• Managing Health Hazard Evaluations from initiation through completion, leading cross-functional teams through process, ensuring timely completion
• Collaborating closely with leadership in Quality & Medical Affairs on the development/approval of HHEs
• Providing direction/guidance to Recall team on execution of Recalls with customers, distributors, and regional RAQA representatives
• Leading all Recall reporting activities to US FDA, EU Competent Authorities and other Health Authorities globally
• Ensuring reporting requirements are compliant with CSI Policy in accordance with applicable global laws & regulations
• Collaborating closely with CSI cross-functional leaders across various Business Units & Global Markets
• Resolving Regulatory Agency/Health Authority requests in relation to reportable Corrections and Removals
• Maintaining and monitoring HHE/Recall Key Performance Indicators (KPI)
• Establishing and maintaining department metrics that complement CSI goals, targets, and objectives
• Assessing and identifying process improvements, developing and implementing business solutions related to Recall process
• Serving as CSI’s Recall Process Owner and Subject Matter Expert
• Ensuring Recall procedures and processes are compliant with all applicable global regulations
• Staying apprised of latest developments in the global regulatory landscape related to Recalls
• Managing, developing and mentoring Recall team
• Performing other duties as assigned

Travel: This position may require 0-10% domestic and/or foreign travel.

Qualifications

• 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

Requirements

• 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
• Experience in Risk Management preferred

Benefits

• Outstanding total compensation plan
• Medical coverage
• 401(k)
• Parental leave
• Fertility benefits
• Paid time off for vacation, personal, sick and holidays
• Multiple other perks and benefits