Director, Post Market Vigilance Team, Microbiology
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About The Position
The Director of the Post Market Vigilance Team in Microbiology is a pivotal role within bioMérieux, responsible for overseeing the Microbiology Vigilance Operational Team (VOT). This position can be based in either St. Louis, MO, or Durham, NC, and is crucial for managing the Vigilance process, which includes the review and approval of incident reporting decisions in the United States. The Director will also manage the Field Action Board process for all Microbiology product lines, serving as the key contact for competent authorities regarding vigilance and field action activities. This role requires effective communication with the FDA concerning Field Safety Corrective Actions (FSCAs), Medical Device Reports (MDRs), terminations, and follow-up actions. The ideal candidate will have a strong background in vigilance or correction and removal roles within the medical device industry, particularly with experience in software, reagents, and laboratory instrumentation. The Director will be responsible for ensuring compliance with internal procedures and directives, training employees as necessary, and staying updated on regulatory changes. This position also involves managing the Microbiology VOT team, which includes responsibilities for training, budget management, and recruitment, as well as participating in audits and inspections. The Director will contribute to quality improvement projects and manage department projects as assigned, ensuring that the team meets its objectives and adheres to regulatory standards.
