Spec Product Recall Sr

Medline•Mundelein, IL

1d•$23 - $34

About The Position

Under limited supervision, the Senior Recall Specialist leads and oversees complex product recall activities, serving as a subject‑matter expert for both sub‑recall and company‑initiated recall notifications in accordance with internal procedures and applicable FDA regulations. This role independently executes and coordinates recall activities, including regulatory communications and FDA effectiveness checks, while providing guidance, training, and oversight to Recall Specialists. The Senior Recall Specialist serves as a primary liaison between the company and the FDA district office, supports continuous improvement initiatives, and ensures consistent, compliant execution of recall processes across the organization.

Requirements

High School Diploma or GED required; Associate or Bachelor’s degree in a related discipline preferred.
Requires 3–5 years of progressive experience in regulated administrative, quality, or operational roles, including direct involvement with product recalls, regulatory documentation, customer communication, and regulated process execution.
Demonstrated experience interacting with regulatory agencies and supporting or leading recall activities is required.
Strong knowledge of FDA recall requirements and regulated quality processes, with the ability to independently manage complex recall activities.
Clear, professional written and verbal communication skills for interaction with FDA representatives, customers, vendors, and internal teams.
Excellent organizational and attention to detail skills to maintain accurate recall documentation, returned product tracking, and audit readiness.
Ability to interpret and consistently apply regulations and internal procedures while exercising sound judgment with minimal supervision.
Demonstrated ability to train, mentor, and provide functional guidance to recall personnel.
Advanced proficiency in Microsoft Outlook, Word, and Excel, with the ability to quickly learn recall and quality systems.
Ability to manage multiple time sensitive priorities in a fast paced, regulated environment.

Responsibilities

Lead, execute, and coordinate sub‑recall notifications and company‑initiated recall activities in accordance with internal procedures and FDA regulations.
Serve as the primary subject‑matter expert for recall execution, providing guidance to internal stakeholders on regulatory requirements, timelines, and documentation expectations.
Independently manage and respond to FDA effectiveness checks, regulatory inquiries, and follow‑up requests related to recall activities.
Serve as the recall liaison between the company and the FDA district office, facilitating clear, professional, and timely communications.
Organize and oversee designated returned product areas to ensure timely, accurate, and compliant processing of recalled product.
Issue and oversee return labels, RGAs, credits, and replacement products to support effective recall resolution.
Review and respond to internal and external recall‑related communications within established timelines.
Maintain complete, accurate, and audit‑ready records for all sub‑recall and company‑initiated recall activities.
Collaborate with vendors to reconcile recalled product returns and resolve discrepancies.
Provide direction to Quality Control personnel to identify, segregate, and secure affected recalled product to prevent release for sale.
Prepare and present periodic recall status reports, metrics, and summaries for Quality leadership and other stakeholders.
Conduct periodic and quarterly internal audits of recall activities to ensure compliance with internal procedures and regulatory requirements.
Identify, recommend, and implement process improvements to strengthen recall effectiveness, efficiency, and inspection readiness.
Train, mentor, and provide ongoing guidance to Recall Specialists and new recall personnel.
Work proactively and collaboratively with Quality Assurance, Quality Engineering, Operations, Sales, and other cross‑functional teams to support recall execution and continuous improvement.