Manager, Regulatory Trade Compliance

Job not on LinkedIn

🕒 April 16

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $116k - $174k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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Medline Industries, LP

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1910

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 Private Equity Round on 2021-06

Healthcare Insurance • Pharmaceuticals

Medline Industries, LP is a leading healthcare company that focuses on improving clinical, financial, and operational outcomes for its customers. The company offers a wide array of over 335,000 medical products and boasts extensive warehousing capabilities with more than 28 million square feet of space. With a significant global presence of 43,000 employees, Medline provides agile and scalable solutions across all points of care, achieving a 95% next-day delivery rate within the US. The company's mission is to enhance healthcare delivery by providing superior products, supply chain resilience, and clinical expertise, all while fostering strong customer relationships through tailored, problem-solving solutions.

📋 Description

• Serve as the Regulatory Affairs subject matter expert for FDA import requirements and ACE submissions for medical devices and medical kits. • Provide regulatory guidance to Imports and Logistics teams to ensure accurate FDA data transmission through the Automated Commercial Environment (ACE). • Oversee and validate FDA entry data elements. • Act as the escalation point for complex FDA import questions and compliance determinations. • Design and implement standardized processes to ensure consistency of FDA-critical data. • Develop and maintain SOPs, work instructions, and internal controls related to FDA import compliance. • Serve as the primary Regulatory Affairs contact for FDA detentions and Notices of FDA Action (NOAs).

🎯 Requirements

• Bachelor’s degree in Regulatory Affairs, Life Sciences, International Trade, Supply Chain, or a related field • Minimum 5 years of experience in FDA-regulated industry • Demonstrated experience creating and implementing business processes and governance controls • Experience managing import compliance for medical kits / convenience kits • FDA medical device import and registration requirements • ACE entry submissions and troubleshooting • Resolution of FDA detentions and Notices of Action • Experience translating regulatory requirements into operational processes

🏖️ Benefits

• health insurance • life and disability • 401(k) contributions • paid time off • Employee Assistance Program • Employee Resource Groups • Employee Service Corp