Senior Regulatory Affairs Specialist

🔥 12 hours ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $92k - $138k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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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 critical and complex global regulatory projects to obtain and maintain regulatory approvals • Prepare comprehensive regulatory strategies for new devices, launch markets, and post-market device changes • Determine requirements for product submissions and regulatory filings in assigned markets • Identify factors affecting new product launch success or viability • Monitor regulatory changes affecting requirements and compliance • Communicate regulatory requirements to internal and external customers • Recommend regulatory pathways, strategies, and solutions • Review supporting evidence for regulatory compliance • Complete and maintain regulatory filings by leading internal groups and collaborating with external groups • Evaluate technical information and write summary documentation • Provide direction on product/project changes and respond to regulator questions and non-conformances • Participate in product labeling and claims development, review, and substantiation • Manage projects, timelines, project teams, and future actions • Assist with regulatory process development and review • Maintain department databases, logs, and files • Participate in internal and external audits

🎯 Requirements

• B.A. or B.S. degree in life science, engineering, medical technology, regulatory science, or related field • 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 for compliance with standards, laws, and regulations • Ability to travel up to 10%

🏖️ Benefits

• Competitive total rewards package • Continuing education & training • Health insurance • Life and disability insurance • 401(k) contributions • Paid time off • Employee Assistance Program access • Employee Resource Groups • Employee Service Corp access • Career growth opportunities