Senior Regulatory Affairs Specialist

Job not on LinkedIn

16 hours ago

🌽 Illinois – Remote

Although this job is listed in Illinois, this company may be open to hiring remote in other states.

💵 $96.2k - $144.6k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Medline Industries, LP

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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.

10,000+ employees

Founded 1910

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 Private Equity Round on 2021-06

📋 Description

• Plan and execute critical and complex global regulatory projects • Prepare comprehensive regulatory strategies for new devices and markets • Monitor changes in regulations impacting compliance • Communicate requirements of regulations to customers • Recommend regulatory pathways and solutions • Review and provide direction to ensure supporting evidence meets regulatory requirements • Manage individual projects defining timelines and recommending actions • Actively participate in internal and external audits

🎯 Requirements

• B.A. or B.S. degree in life science field, engineering, regulatory science, 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 • Applied knowledge of FDA regulations and guidelines • Ability to evaluate information to determine compliance with standards, laws, and regulations • Position requires up to 10% travel

🏖️ Benefits

• Health insurance • Life and disability • 401(k) contributions • Paid time off