NEW JOB OPENING
REGULATORY AFFAIRS COORDINATOR
IN Redmond, WA, USA!

Education Required:

• High School Diploma or Equivalent



Job 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.**