Job Title: Administration Coordinator
Location: Redmond, WA
Type: Contract
Compensation: $24.00
Contractor Work Model: Onsite
Hours: 8:00am to 5:00pm

Responsibilities

• Coordinate Product Field Action (PFA) executions according to defined strategies, procedures, and regulations.
• Oversee and coordinate all field-related activities scoped within PFA executions.
• Ensure PFA executions are compliant with regional regulations and guidance, focusing on US customers and FDA requirements.
• Work directly with management to ensure timely notification to regulatory agencies.
• Report regularly to keep management informed of PFA execution status.
• Serve as a member of the divisional PFA team to establish, implement, and maintain global regulatory and quality processes and documents supporting the Global QMS.
• Maintain a customer-centric approach by ensuring field actions are completed promptly and meet or exceed customer expectations.
• Call/email customers to inform them of the product field action and carry out the defined strategy.
• Maintain PFA execution tracking and documentation.

Requirements

• Experience coordinating product field actions or similar regulatory activities preferred.
• Strong understanding of FDA regulations and regional compliance standards.
• Excellent communication skills for customer contact and internal reporting.
• Ability to work independently and coordinate multiple activities simultaneously.
• Proficiency in documentation and tracking systems related to regulatory processes.
• High school diploma or equivalent required; additional education or certifications in regulatory affairs or related fields are a plus.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #558-Scientific