Administration Coordinator

Wilson•Redmond, WA
•Onsite

About The Position

The Administration Coordinator will coordinate Product Field Action (PFA) executions according to defined strategies, procedures, and regulations. The role oversees field-related activities within PFA executions and helps ensure compliance with regional regulations and guidance, with a primary focus on FDA requirements. The coordinator works with management on timely regulatory-agency notifications and regular status reporting, and participates on the divisional PFA team to establish, implement, and maintain global regulatory and quality processes and documents supporting the Global Quality Management System. The role involves coordinating recall and field-action activities, including customer communications and concerns, and working with internal teams, international partners, and regulatory agencies. The position is based at 11811 Willows Rd NE, Redmond, Washington. The stated assignment is three months, with a possible extension and potential future conversion subject to budget approval. The scheduled hours are 8:00 a.m.–5:00 p.m. Pacific, with flexibility in start and end times depending on support needs; some overtime may be possible.

Requirements

  • High school diploma and at least 2 years of relevant experience.
  • Experience coordinating regulated activities, tracking deliverables, and maintaining execution documentation.
  • Experience supporting regulatory or quality-system requirements, including clear written communication and accurate records.
  • At least 2 years of relevant project coordination experience managing timelines, priorities, status reporting, and cross-functional coordination.
  • Strong time-management, writing, coordination, and basic regulatory-execution skills.
  • Ability to coordinate and support technical and scientific field-action activities.
  • Interpersonal communication, collaborative teamwork, and negotiation skills.
  • Ability to compose routine communications to regulators and other key stakeholders.
  • Ability to build trusting relationships across management levels and communicate clearly with peers, supervisors, and stakeholders.
  • Ability to prepare and explain detailed assessments and execution plans, and accurately identify potential challenges.
  • Ability to use project-record software such as MS Office, TrackWise, SharePoint, or Visio.
  • Ability to work with concerned or frustrated customers, using strong written and verbal communication and diplomacy.
  • Ability to work under supervision on varied, somewhat difficult work that usually involves limited responsibility.
  • Subject-matter expertise in applicable RAQA and Stryker business requirements for the area of ownership.
  • Willingness to seek diverse ideas and perspectives, relate to people with different viewpoints, and accept feedback as an opportunity to improve.

Nice To Haves

  • Coordinator or Product Field Action (PFA) experience.
  • Prior project management experience.
  • Medical-device industry experience or experience in another regulated environment, particularly in Quality, Regulatory Affairs, recalls, or field actions.
  • Experience supporting audits, regulatory communications, or international partners.

Responsibilities

  • Maintain standardized processes and procedures for executing field actions, including working with international partners to support effective completion.
  • Maintain PFA execution tracking and documentation.
  • Ensure field activities comply with relevant regulatory requirements, industry standards, and company policies.
  • Advise on corporate PFA execution policies and help ensure the Stryker Redmond and Belfast procedures are current and aligned with other quality-system procedures.
  • Develop and provide training on the PFA execution process.
  • Support internal and external audit activities related to PFA executions.
  • Communicate notifications and status updates about PFA executions to regulatory agencies.
  • Provide regular updates to management on the status and completion of PFA executions.
  • Coordinate with PFA process leads, site execution owners, engineers, technicians, and other internal stakeholders on field-action deliverables.
  • Communicate with customers, business users, management, cross-functional stakeholders, international partners, and regulatory agencies, including responding to customer concerns.
  • Help ensure field actions are completed promptly and meet or exceed customer expectations.
  • Perform other related duties as assigned.
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