What are the responsibilities and job description for the Quality & Regulatory Affairs Coordinator position at Pace Staffing Network?
Are you a detail-oriented professional with experience coordinating projects, maintaining regulatory documentation, and managing multiple priorities? Our client is seeking a Quality & Regulatory Affairs Coordinator to support product field actions, including recalls, regulatory communications, and quality compliance activities. This role is ideal for someone who can independently manage detailed projects, communicate effectively with stakeholders, and ensure activities are completed accurately and on time.
You’ll Be Doing
- Coordinate and manage product field actions, including recalls, customer communications, documentation, and follow-up activities
- Track field action activities, project timelines, deliverables, and completion status to ensure timely execution
- Maintain accurate regulatory documentation, records, and tracking systems in accordance with established procedures and FDA requirements
- Communicate with customers, internal teams, management, and regulatory agencies regarding field action activities, updates, and outstanding requirements
- Collaborate with cross-functional teams, including quality, regulatory, engineering, and international partners, to coordinate field action execution
- Identify and resolve issues, respond to customer concerns, and ensure field action activities remain on track
- Support quality system procedures, audit activities, process improvements, and regular reporting to management
What We’re Looking For
- 2 years of relevant experience coordinating projects, regulatory activities, quality processes, or other detail-oriented operational work
- Experience tracking deliverables, maintaining accurate documentation, managing timelines, and coordinating activities across multiple stakeholders
- Familiarity with regulatory or quality system requirements and maintaining documentation in accordance with established procedures
- Strong written and verbal communication skills with the ability to work effectively with customers, management, and cross-functional teams, including handling challenging customer interactions
- Excellent organizational skills, attention to detail, and the ability to independently manage priorities and follow projects through completion
- Proficiency with Microsoft Office and other tracking or documentation systems; experience with TrackWise, SharePoint, or Visio is a plus
- Previous experience in medical devices, regulated industries, product recalls, or Product Field Actions (PFA) preferred
- High school diploma required; prior project management experience is a plus
Additional Details
Location: Redmond, WA | Hybrid (Monday–Wednesday onsite, Thursday–Friday remote)
Schedule: Monday–Friday, 8:00 AM–5:00 PM
Pay Rate: $24/hour
Assignment: Temporary assignment approved through December 2026, with anticipated extension of at least three additional months
PACE Staffing Network is a woman-owned staffing company serving Washington employers for over 45 years. We place temporary, contract, and direct-hire professionals across healthcare administration, manufacturing, quality, regulatory affairs, HR, accounting, executive support, and operations.
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