Senior Regulatory Affairs Specialist

Job not on LinkedIn

🕒 June 18

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $92k - $138k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Medline Industries, LP

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1910

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

💰 Private Equity Round on 2021-06

Healthcare • Logistics • Manufacturing

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

• Plan and execute global regulatory projects for approvals • Prepare regulatory strategies for new devices and markets • Ensure supporting information meets regulatory requirements • Develop solutions to complex regulatory issues • Manage individual projects and define timelines • Participate in audits and maintain compliance databases

🎯 Requirements

• B.A. or B.S. degree in life science field, engineering, medical technology, or related • At least 4 years of experience in regulatory affairs in the medical device industry • Experience authoring and submitting regulatory submissions including 510(k)s and/or CE Technical Files • Experience preparing responses and communicating with regulatory agencies • Understanding of the current Regulatory environment and ability to perform within • Applied knowledge of FDA regulations and guidelines • Ability to evaluate information for compliance with standards, laws, and regulations • Up to 10% travel required

🏖️ Benefits

• Health insurance • Life and disability insurance • 401(k) contributions • Paid time off • Employee Assistance Program • Employee Resource Groups • Employee Service Corp