Regulatory Affairs Specialist

Job not on LinkedIn

🕒 July 6

🇺🇸 United States – Remote

💵 $79k - $119k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

👻 Ghost score 3%

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Logo of Medline Industries, LP

Medline Industries, LP

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

• planning and executing global regulatory activities necessary to obtain and maintain global regulatory approvals • Prepare comprehensive regulatory strategies for new devices and markets • Review and provide feedback on documentation to ensure regulatory requirements are met • Complete and maintain regulatory filings by collaborating with internal and external groups • Present project objectives with team members and act as a regulatory resource

🎯 Requirements

• B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related • 2 years of experience in medical device regulatory affairs or quality assurance • Understanding of the current Regulatory environment • Applied knowledge of FDA regulations and guidelines • Ability to evaluate information to determine compliance with standards, laws, and regulations • Travel required up to 5%

🏖️ Benefits

• health insurance • life and disability • 401(k) contributions • paid time off

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