Regulatory Affairs Coordinator

Product Field Action CoordinatorEducation Required: High School Diploma or EquivalentJob Requirements:Minimum 2 years of experience coordinating regulated activities, tracking deliverables, and maintaining execution documentation.Experience supporting Quality Assurance (QA), Regulatory Affairs (RA), or Quality Management System (QMS) processes.Experience managing project timelines, priorities, status reporting, and cross-functional coordination.Strong written and verbal communication skills, including interaction with customers, management, and regulatory agencies.Ability to work independently and drive Product Field Action (PFA) or recall activities from initiation through completion.Strong organizational, time management, and attention-to-detail skills.Experience maintaining accurate regulatory documentation and execution records.Ability to coordinate with cross-functional teams, international partners, engineers, technicians, and quality stakeholders.Ability to communicate professionally with concerned or frustrated customers.Knowledge of FDA regulations, quality systems, or other regulated industry requirements.Flexibility to work occasional overtime as business needs require.Preferred Skills:Proficiency with Microsoft Office; experience with TrackWise, SharePoint, or Visio is preferred.Experience supporting internal and external audits is preferred.Prior Product Field Action (PFA), recall coordination, or project management experience is preferred.Medical device or other regulated industry experience is preferred.Job Summary:Coordinate Product Field Action (PFA) executions (product recalls and field actions) in compliance with FDA regulations, company procedures, and quality system requirements. Manage field action activities from planning through completion, ensuring timely execution and accurate documentation. Track project deliverables, execution status, and maintain detailed regulatory records. Collaborate with cross-functional teams, international partners, engineers, technicians, and site execution owners to ensure successful field action completion. Communicate with customers, management, and regulatory agencies regarding recall activities, notifications, and execution status. Support Global Quality Management System (QMS) processes by maintaining PFA procedures and ensuring regulatory compliance. Prepare status reports and provide regular updates to leadership on Product Field Action progress and completion. Support internal and external audits related to Product Field Actions and regulatory compliance. Develop and deliver training on Product Field Action execution processes and procedures. Maintain a customer-focused approach while independently managing multiple recall projects in a fast-paced, highly regulated medical device environment.**Only those lawfully authorized to work in the designated country associated with the position will be considered.****Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client's business needs and requirements.**