Manager- Post Market Surveillance (Recall)

CooperCompanies • Livingston, NJ

3d • $107,000 - $150,000 • Onsite

About The Position

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.

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.

Nice To Haves

• Experience in Risk Management preferred.

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.

Benefits

• outstanding total compensation plan
• great compensation package
• medical coverage
• 401(k)
• parental leave
• fertility benefits
• paid time off for vacation, personal, sick and holidays
• multiple other perks and benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Manager