Regulatory Field Action Coordinator

System One; Redmond (WA); Hybrid; USD 27,000 - 39,000; Part time

Benefits offered by this job

Health benefits

401(k) plan

Job summary

System One in Redmond, WA is seeking a Contract Product Field Action Coordinator to oversee and coordinate field actions under FDA guidance. The role combines onsite and remote work with a hybrid schedule: Monday to Wednesday onsite, Thursday and Friday remote, 8:00–5:00.

You will maintain PFA execution records, ensure regulatory compliance, and report status to management, while collaborating with cross-functional teams and external partners to deliver timely actions and training.

Qualifications

• High school diploma plus 2+ years of relevant experience.
• Associates or Bachelor's degree preferred.

Responsibilities

• Maintain standardized process and procedure for executing field actions.
• Maintain PFA Execution tracking and documentation.
• Ensure field activities adhere to regulatory requirements, industry standards and company policies.
• Provide training for PFA Execution process.
• Support internal and external audit activities relating to PFA Executions.
• Communicate with regulatory agencies on notifications and status of PFA Executions.
• Provide regular updates to management on status and completion of PFA Executions.
• Collaborate with internal stakeholders to ensure seamless coordination and communication.

Skills

Interpersonal communication

Coordination

Negotiation

Time management

Written communications

Education

High school diploma

Associates or Bachelor's degree preferred

Tools

MS Office

TrackWise

SharePoint

Visio

Job description

System One in Redmond, WA is seeking a Contract Product Field Action Coordinator to oversee and coordinate field actions under FDA guidance. The role combines onsite and remote work with a hybrid schedule: Monday to Wednesday onsite, Thursday and Friday remote, 8:00–5:00.

You will maintain PFA execution records, ensure regulatory compliance, and report status to management, while collaborating with cross-functional teams and external partners to deliver timely actions and training.