Coordinator, Administration - Skilled

Job Description:
Quality Regulatory Affairs (QRA) Coordinator, Product Field Action (PFA):

Scope of the role
PFA/QA Coordinator

Position summary
Responsible for coordinating PFA Executions according to defined strategies, procedures and regulations. As a QRA Coordinator, PFA, responsible to oversee and coordinate all field-related activities scoped within PFA Executions. Responsible for ensuring the PFA Executions are executed in compliance with regional regulations and guidance, primarily focusing on FDA requirements. Works directly with management to ensure timely notification to regulatory agencies. Reports on a regular basis to ensure management is informed of PFA Execution status.
Serves as a member of divisional PFA team to establish, implement, and maintain Global Regulatory and Quality processes and documents supporting our Global QMS.

Key areas of responsibility
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  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.

Education / work experience
High school diploma plus 2%2B years of relevant experience / For conversion, confirming if degree is required
Coordinator or PFA experience is preferred.
Prior project management experience is a plus.

Knowledge / competencies
Time management skills, writing, coordination, and execution of basic regulatory items.
Coordinate and support technical and scientific field action activities.
Under supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility.
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.
Subject matter expert for the RAQA and -business requirements of their area of ownership.
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.

Notes:
The candidate will communicate with customers, business users, management, cross-functional stakeholders, international partners, and regulatory agencies. Strong written and verbal communication, diplomacy, and the ability to work with concerned or frustrated customers are important.
Industry experience is desired. Experience in the medical device industry or another regulated environment, particularly Quality, Regulatory Affairs, recalls, or field actions, is preferred.
Some potential for OT at some point, but not ideal
Current team: The team currently includes one full-time PFA coordinator overseeing recalls for Redmond and Belfast. This role will also work closely with PFA process leads, site execution owners, engineers, technicians, management, and a manager based in Dallas.
Very tedious tasks, so people sometimes dont like it.
Was initially to work on 1 product recall, calling customers, responding to customers comms and concerns; can be working with frustrated customers, etc.
Current position approved through EOY. Intends to extend another 3 months at least. Ideally wants to convert this person to FTE next year pending budget approval.
Dont want someone to come in and just pick up the phone. Looking for someone who can manage their own, drive their own recalls.
Has 1 FTE coordinator currently who oversees all recalls in Redmond & Belfast -- Joyce Staggs; (example profile for strong fit for this role)

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

Nice To Haves:
Coordinator or Product Field Action (PFA) experience preferred; no minimum years specified.
Prior project management experience preferred; no minimum years specified.
Medical device or other regulated-industry experience preferred; no minimum years specified.
Experience with MS Office, TrackWise, SharePoint, or Visio preferred.
Experience supporting audits, regulatory communications, or global partners preferred.

Interview Process:
Two 45-minute interviews (virtual): the first with Evelyn and the second with the Product Field Action subject matter expert in Dallas.

Hybrid role - M-W onsite; Th-Fr remote. 8-5

Comments for Suppliers:
Job Title: Quality Regulatory Affairs (QRA) Coordinator, Product Field Action (PFA)