Product Field Action Coordinator

Product Field Action Coordinator

6-Month+ Contract | 1st Shift | Monday-Friday, 8:00 AM-5:00 PM | HYBRID Work Schedule,  Monday through Wednesday onsite with Thursday and Friday remote.  

Our client, a Global Leader in the Medical Device Industry, has an immediate opening for a Product Field Action Coordinator for a 6-month+ Contract to Hire role.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed, and detail-oriented Top Talents in an extremely collaborative and professional environment.

Responsible for coordinating PFA (Product Field Action) Executions according to defined strategies, procedures, and regulations. As a PFA Coordinator, you will oversee and coordinate all field-related activities within PFA Executions. Ensures PFA Executions comply with regional regulations and guidance, primarily FDA requirements. Works directly with management to ensure timely notification to regulatory agencies. Reports regularly to keep management informed of PFA Execution status.
 
 Serves as a member of the divisional PFA team to establish, implement, and maintain Global Regulatory and Quality processes and documents supporting our Global QMS.

MUST HAVES:

1. Relevant experience coordinating regulated activities, tracking deliverables, and maintaining execution documentation.
 2. Experience supporting regulatory or quality-system requirements, including clear written communication and accurate records.
 3. Project coordination and stakeholder communication: 2+ years of relevant experience managing timelines, priorities, status reporting, and cross-functional coordination with internal teams, management, customers, or regulators.

Duties and Responsibilities

• Maintain standardized process and procedure for executing field actions, including but not limited to working with international partners to ensure effective field action completion.
• Maintain PFA Execution tracking and documentation.
• Ensure that all field activities adhere to relevant regulatory requirements, industry standards, and company policies.
• Provide advice on corporate PFA Execution policies, ensuring that the clients Redmond and Belfast PFA Execution Procedures are current and are aligned with other Quality System Procedures.
• Develop and provide training for PFA Execution process.
• Support internal and external audit activities relating to PFA Executions.
• Communicate with regulatory agencies on the notifications and status of PFA Executions.
• Provide updates on a regular basis to management regarding status and completion of PFA Executions.
• Collaborate with internal stakeholders, such as PFA process leads, site execution owners, engineers, and technicians, to ensure seamless coordination and communication regarding field action deliverables.
• Maintain a customer-centric approach by ensuring that field actions are completed promptly and meet or exceed customer expectations.
• Perform other related duties as assigned.

Requirements

• High school diploma plus 2+ years of relevant experience for contract.  Degree required for client conversion.
• Coordinator or PFA experience is preferred.
• Prior project management experience is a plus.  
• Time management skills, writing, coordination, and execution of basic regulatory items.
• Coordinate and support technical and scientific field action activities.
• Interpersonal communication, collaborative teamwork and negotiation skills. Composes routine communications with regulators and other key stakeholders
• Ability to build trusting relationships with all levels of management and clearly conveys information to peers, supervisors, and other stakeholders.
• Ability to generate and explain detailed assessments, execution plans, and any potential challenges accurately.
• Utilize proper software to maintain project records such as MS Office, TrackWise, SharePoint, or Visio.
• Seeks out diverse ideas, opinions, and insights, and applies them in the workplace.
• Connects and relates well with people who think and act differently than oneself.
• Embraces scrutiny and accepts feedback as opportunity to learn and improve.