Spec Product Recall Sr

Medline; Mundelein (IL); On-site; USD 66,621,000 - 96,708,000; Full time

Benefits offered by this job

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Job summary

Medline, Mundelein, IL, seeks a Senior Recall Specialist to lead complex recall activities under limited supervision. You will coordinate sub-recalls and company recalls, act as the primary SME for regulatory requirements, and serve as the main liaison with the FDA district office.

You will train Recall Specialists and drive continuous improvement in recall execution. You will manage FDA effectiveness checks, regulatory inquiries, and documentation, ensuring audit-ready records and compliant

Qualifications

• 3–5 years of regulated administrative, quality, or operational experience, including product recalls.
• Experience interacting with regulatory agencies and supporting recall activities is required.
• Ability to maintain audit-ready documentation and respond to inquiries in a timely manner.

Responsibilities

• Lead and coordinate sub-recall and company-initiated recall activities per internal procedures and FDA rules.
• Serve as the SME for recall execution; guide stakeholders on regulatory timelines and documentation expectations.
• Respond to FDA inquiries and effectiveness checks; manage communications with the FDA district office.
• Organize returned product areas to ensure compliant processing; oversee labels, RGAs, credits, and replacements.
• Maintain complete recall records and generate status reports for Quality leadership.
• Collaborate with cross-functional teams to improve recall processes and training for Recall Specialists.

Skills

FDA recall requirements

Regulatory documentation

Regulated quality processes

Written communication

Organizational skills

Training & mentoring

Education

Associate or Bachelor's degree

Tools

Microsoft Office

Excel

Outlook/Word

Job description

Job Summary

JOB SUMMARY

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.

Job Description

MAJOR 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.
• Lead, execute, and coordinate sub-recall notifications and company-initiated recall activities in accordance with internal procedures and FDA regulations.

Minimum Job Requirements

Education

High School Diploma or GED

Work Experience

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.

Knowledge / Skills / Abilities

• 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.

Preferred Job Requirements

Education

Associate or Bachelor's degree in a related discipline preferred.

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The Anticipated Salary Range For This Position

$23.25 - $33.75 Hourly

The actual salary will vary based on applicant's location, education, experience, skills, and abilities. Medline will not pay less than the applicable minimum wage or salary threshold.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.

We're dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.