Coordinator, Administration - Skilled

Aston Carter; Redmond; Hybrid; AUD 39,000 - 56,000; Full time

Job summary

Aston Carter is seeking a Quality Regulatory Affairs (QRA) Coordinator for Product Field Action (PFA) coordination in Redmond, WA. The role focuses on recalls, customer notifications, device replacements, and regulatory-driven actions with emphasis on FDA compliance and global quality standards.

You will manage PFAs end-to-end, communicate with customers and agencies, and collaborate with QA, regulatory, manufacturing, and engineering teams to ensure timely, compliant action closures.

Qualifications

• At least 2+ years coordinating regulated activities or operational processes.
• Experience supporting quality systems, regulatory requirements, or compliance programs.
• Strong project coordination skills with timeline management and stakeholder communication.
• Ability to work cross-functionally with internal teams and external stakeholders.
• Excellent written and verbal communication in a regulated environment.
• Detail-oriented with meticulous record-keeping.

Responsibilities

• Coordinate and execute Product Field Actions (PFAs), including recalls and customer notifications.
• Manage field actions from initiation to completion with adherence to procedures and timelines.
• Track progress, milestones, and completion metrics for all actions.
• Maintain compliant records throughout field action lifecycles.
• Identify risks and communicate mitigation plans to stakeholders.
• Support FDA regulations, QMS, and regional standards for field actions.
• Prepare and review documentation for field actions and recalls.
• Communicate with regulatory agencies as required.
• Ensure actions align with internal policies and QMS requirements.
• Support audits by providing documentation and status updates.
• Act as coordination point between QA, regulatory, manufacturing, and other teams.
• Engage with customers regarding action status and resolutions.
• Provide updates to leadership on progress and outcomes.
• Collaborate with international partners for global action consistency.
• Contribute to improving field action procedures and processes.
• Assist training on PFAs and share best practices.
• Explore process improvements to boost efficiency and compliance.
• Serve as a knowledge resource on field action processes.

Skills

Regulatory coordination

Quality systems

FDA compliance

Project coordination

Cross-functional collaboration

Documentation

Microsoft Office

Audit support

PFA/recall familiarity

Tools

TrackWise

SharePoint

Visio

Job description

Job Title: Quality Regulatory Affairs (QRA) Coordinator, Product Field Action (PFA)

Job Description

The Quality Regulatory Affairs (QRA) Coordinator, Product Field Action (PFA) coordinates and executes product field actions, including recalls, customer notifications, device replacements, and other regulatory-driven activities. The role ensures that all field actions follow defined strategies, procedures, and regulatory requirements, with a strong focus on FDA compliance and global quality system standards. The coordinator independently manages recall activities, drives execution efforts, and communicates confidently with customers, even in situations involving concerns, escalations, or dissatisfaction. This position offers high visibility, cross-functional and international exposure, and the opportunity to build expertise in regulatory affairs, quality systems, and medical device compliance.

Responsibilities

• Coordinate and execute Product Field Actions (PFAs), including product recalls, customer notifications, device replacements, and other regulatory-driven activities.
• Manage assigned field actions from initiation through completion while ensuring adherence to established procedures, timelines, and regulatory requirements.
• Track execution progress, milestones, deliverables, and completion metrics for all assigned field actions.
• Maintain accurate, complete, and compliant records and documentation throughout the lifecycle of field action activities.
• Identify execution risks, obstacles, and delays and proactively communicate mitigation plans to relevant stakeholders.
• Support compliance with FDA regulations, quality system requirements, and applicable regional regulatory standards related to field actions.
• Prepare, maintain, and review documentation associated with field actions and recall activities to ensure accuracy and regulatory alignment.
• Communicate with regulatory agencies regarding field action notifications, status updates, and completion activities as required.
• Ensure all field action activities align with internal policies, quality standards, and global quality management system requirements.
• Support internal and external audits related to field action activities by providing documentation, status updates, and process explanations.
• Serve as a primary coordination point between quality, regulatory, manufacturing, engineering, operations, and other internal teams involved in field actions.
• Communicate regularly with customers regarding field actions, product concerns, and execution status, ensuring clear and timely information.
• Effectively manage interactions with concerned, frustrated, or escalated customers while maintaining professionalism and a strong customer focus.
• Provide updates and status reports to leadership and key stakeholders on the progress and outcomes of field actions.
• Collaborate with international partners and regional teams to ensure successful completion of global field actions and consistent execution across regions.
• Support the development, maintenance, and continuous improvement of field action procedures, tools, and processes.
• Assist with training initiatives related to Product Field Action execution, including sharing best practices and process updates.
• Recommend process enhancements to improve execution efficiency, regulatory compliance, and documentation quality.
• Serve as a knowledgeable resource on field action processes and quality-system requirements within the assigned area of responsibility.

Essential Skills

• At least 2+ years of experience coordinating regulated activities, projects, or operational processes.
• Experience tracking deliverables, maintaining documentation, and managing execution workflows in a controlled environment.
• Experience supporting quality systems, regulatory requirements, compliance programs, or other controlled processes.
• Strong project coordination experience, including timeline management, prioritization, status reporting, and stakeholder communication.
• Ability to work cross-functionally with internal teams, customers, leadership, and external stakeholders.
• Strong written and verbal communication skills with the ability to communicate clearly and professionally.
• High attention to detail and the ability to maintain accurate records in a regulated environment.
• Proficiency with Microsoft Office Suite.
• Demonstrated customer service skills, including handling inquiries, concerns, and escalations in a professional manner.
• Experience providing audit support or working within environments subject to audits.
• Familiarity with product field action (PFA) or recall-related activities in a regulated context.
• Exposure to medical device, healthcare, or other regulated product environments.

Additional Skills & Qualifications

• Experience with Product Field Action (PFA) coordination, recall coordination, or field action execution.
• Experience in the medical device industry.
• Experience working within regulated industries such as healthcare, pharmaceuticals, biotechnology, manufacturing, aerospace, or life sciences.
• Prior project management experience, including managing multiple initiatives and stakeholders.
• Experience communicating with regulatory agencies regarding field actions or related activities.
• Experience supporting internal or external audit activities.
• Experience working with international stakeholders or global business partners.
• Experience with quality management systems such as TrackWise.
• Experience with collaboration and documentation tools such as SharePoint.
• Experience using Visio or similar tools to document processes or workflows.
• Interest in developing expertise in regulatory affairs, quality systems, and global product support.
• Desire to contribute to initiatives that directly impact customer safety and product compliance.

Job Type & Location

This is a Contract position based out of Redmond, WA.

Pay and Benefits

The pay range for this position is $24.00 - $24.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness
• Accident, and Hospital
• 401(k) Retirement Plan
• Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Application Deadline

This position is anticipated to close on Oct 31, 2026.

Workplace Type

This is a hybrid position in Redmond,WA.

About Aston Carter

Aston Carter provides world-class corporate talent solutions to thousands of clients across the globe. Specialized in accounting, finance, human resources, talent acquisition, procurement, supply chain and select administrative professions, we extend the capabilities of industry-leading companies. We draw on our deep recruiting expertise and expansive network to meet the evolving needs of our clients and talent community with agility and excellence. With offices across the U.S., Canada, Asia Pacific and Europe, Aston Carter serves many of the Fortune 500. We are proud to be a ClearlyRated Best of Staffing® Platinum Award winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] ([e-mail]) for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.