Principal Regulatory Affairs

🕒 October 9

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $116k - $174k / year

⏰ Full Time

🔴 Lead

🚔 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

• Develop regulatory strategies for global approvals introducing new products to market and maintaining existing products • Negotiate with regulatory authorities and inform future product development • Resolve regulatory issues independently and provide direction on large-scale projects • Determine requirements for product submissions and regulatory filings for clearance/approval in assigned markets • Identify and solve factors affecting new product launch success or viability • Monitor regulatory changes and execute necessary compliance changes • Acquire and apply harmonized standards knowledge • Communicate regulatory requirements to internal and external customers • Recommend regulatory pathways, strategies, solutions, and future actions • Review evidence for compliance with regulations, guidance documents, and standards • Lead regulatory filings and coordinate internal and external groups • Communicate with regulators regarding non-conformances and questions • Lead product labeling and claims development, review, and substantiation • Manage complex projects, timelines, technical deliverables, and multifaceted teams • Improve and develop regulatory-driven and technical processes • Maintain compliance databases, logs, and files • Lead audits and manage post-audit corrective actions

🎯 Requirements

• B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related • 5+ years of diverse regulatory experience in the medical device industry • Strong global regulatory background supporting pre- and post-market regulatory activities • Experience with independent regulatory submissions • Experience participating in regulatory intelligence programs • Experience developing and implementing regulatory strategies in multiple international markets • Ability to lead efforts related to risk management and design and development • Extensive experience authoring and submitting regulatory submissions, including 510(k)s and CE Technical Files • Extensive experience communicating and negotiating with regulatory agencies, including FDA and notified bodies • Ability to work independently and lead large-scale projects with significant business impact

🏖️ Benefits

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

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