Senior Regulatory Affairs Specialist

Job not on LinkedIn

🔥 23 minutes ago

🌽 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 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

• Responsible for planning and executing global regulatory projects necessary to obtain and maintain global regulatory approvals • Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes • Identify factors that could impact the success or viability of new product launch in assigned market(s) • Monitor changes in regulations that impact current or future requirements and overall compliance • Communicate requirements of regulations to internal or external customers • Review and provide direction to ensure supporting evidence meets appropriate regulatory requirements • Complete and maintain varied regulatory filings by leading internal groups, collaborating with external groups • Manage individual projects by providing direction on diverse regulatory pathways • Assist in the review and development of processes related to regulatory activities

🎯 Requirements

• B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related • At least 4 years of experience in regulatory affairs in the medical device industry supporting domestic or international markets • 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 to determine compliance with standards, laws, and regulations

🏖️ Benefits

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