Medline Industries, LP
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.
Senior Regulatory Affairs Specialist
Job not on LinkedIn
🕒 May 7
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Medline Industries, LP
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
• planning and executing critical and complex global regulatory projects • Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes • Developing solutions to complex regulatory issues • Leading multifunctional teams in high-priority projects • Determine requirements for product submissions and regulatory filings • Monitor changes in regulations • Communicate requirements of regulations to customers • Recommend regulatory pathways, strategies, and solutions • Review and provide direction on supporting evidence • Complete and maintain varied regulatory filings • Participate in the development, review, and substantiation of product labeling and claims • Manage individual projects by providing direction on regulatory pathways • Assist in the review and development of processes related to regulatory activities • Participate in internal and external audits when applicable
🎯 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 • 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 • Employee Assistance Program • Employee Resource Groups • Employee Service Corp
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