Manager, Regulatory Compliance

Manager, Regulatory Compliance Location: Plano, TX Base Pay: $99,300.00 – $198,700.00 Responsibilities Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Ensure ongoing compliance with FDA regulations (21 CFR Parts 803, 806, 820), EU MDR/IVDR requirements, and applicable global regulations. Monitor and assess global regulatory requirements and product standards (e.g., FDA, EU MDR/IVDR, ISO 13485, ISO 14971). Establish processes for regulatory intelligence gathering and impact analysis. Evaluate the impact of regulatory and standard updates on existing products, processes, and quality systems. Lead implementation of regulatory and standards changes, ensuring alignment with internal processes. Communicate changes to stakeholders and provide guidance on compliance requirements. Translate regulatory requirements into actionable project plans. Monitor project timelines, risks, and deliverables to ensure compliance and timely execution. Support internal and external audits, including regulatory inspections. Develop and maintain policies, SOPs, and work instructions related to recalls and regulatory updates. Lead and manage product recalls, field corrections, and safety notices in compliance with FDA (21 CFR Part 806), EU MDR, and other global regulations. Perform health hazard evaluations (HHEs) and risk assessments to support escalation decisions. Interface with regulatory authorities and notified bodies as needed. Ensure timely reporting to regulatory authorities (e.g., FDA, EMA, Health Canada, MHRA). Monitor recall effectiveness and conduct recall effectiveness checks. Track and report compliance metrics and KPIs to leadership. Required Qualifications Associate’s degree Minimum of 7 years of relevant experience Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned or related functions or groups Facilitates others' participation in the continuous improvement program Investigates and solves problems that impact work processes and personnel within or across units or departments Develops and communicates a vision for the organizational unit assigned Preferred Qualifications Bachelor’s degree preferred Minimum of 2-3 years of people management Strong understanding of regulatory requirements and QMS standards Confidently communicate with regulators, auditors, and leadership Project and program management skills Excellent communication and stakeholder management High attention to detail and organizational skills Job Family: Operations Quality Division: NM Neuromodulation Work Shift: Standard Travel: Not specified Abbott is an Equal Opportunity Employer, committed to employee diversity. EEO is the Law link - English: EEO is the Law link - Espanol: #J-18808-Ljbffr