Manager Regulatory Compliance - Recalls

Job Summary Job Description Major Responsibilities: Manage the recall team, providing coaching and development for team members. Support the planning and execution of voluntary and mandatory recalls, product corrections, and removals in accordance with FDA regulations. Contribute to recall and field action decisions, including recall strategy recommendations. Ensure timely submission of FDA Form 806 and related documentation, including status reports and termination requests. Maintain compliance with 21 CFR Part 7 (Recall Policy) and 21 CFR Part 806 (Reports of Corrections and Removals). Support communications with FDA and assist in preparing responses related to recalls. Monitor regulatory changes related to field actions and adverse event requirements and escalate impacts to leadership.…