Senior Director – Regulatory Intelligence, FDA Engagement

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $203k - $305k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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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 and execute the global regulatory intelligence strategy • Direct enterprise-wide impact assessments for significant regulatory changes • Prioritize regulatory changes based on business, compliance, product, and patient risk • Coordinate cross-functional action plans and executive escalations • Establish governance, policies, procedures, and metrics for regulatory intelligence activities • Build a centralized regulatory intelligence function supporting all product categories and global markets • Develop long-range regulatory risk assessments and strategic forecasting capabilities • Identify emerging regulatory trends and advise leadership on potential business impacts • Prepare dashboards covering regulatory changes, compliance risks, industry trends, emerging enforcement themes, and strategic opportunities • Serve as an enterprise expert in developing, reviewing, and approving regulatory response strategies • Lead preparation of responses to FDA Form 483 observations, FDA Warning Letters, Untitled Letters, regulatory meeting commitments, requests for information, inspection follow-up correspondence, and compliance and enforcement actions • Ensure regulatory responses are scientifically sound, strategically aligned, risk-based, defensible to regulators, and supported by appropriate remediation plans • Guide cross-functional teams through regulatory negotiations, commitments, and remediation activities

🎯 Requirements

• Bachelor’s degree in Regulatory Affairs, biology, microbiology, biomedical engineering, pharmaceutical science, chemistry, life sciences, or related field • 10+ years of progressive Regulatory Affairs and/or Quality leadership experience • 8+ years interacting directly with global health authorities • Significant experience in highly regulated healthcare industries, including Medical Devices, Pharmaceuticals/OTCs, Combination Products, Biologics, Human Tissue/HCT/P products, and Nutritional Supplements • Direct authorship of multiple FDA-483/Warning Letters and other responses to regulatory agencies • Extensive experience authoring, reviewing, and leading regulatory responses to FDA enforcement actions • Direct authorship of multiple FDA Warning Letter responses • Direct authorship of numerous FDA Form 483 responses • Development of remediation commitments and implementation plans • Management of ongoing correspondence with FDA regarding compliance commitments • Leadership of cross-functional teams supporting inspection response and remediation activities • Experience negotiating regulatory commitments and demonstrating effectiveness of corrective actions • Preferred: 15+ years of progressive experience in Quality and/or Regulatory leadership roles • Preferred: Experience establishing or leading a Regulatory Intelligence function • Preferred: Experience supporting enterprise-wide quality transformation or remediation programs • Preferred: Experience operating across FDA, European Commission / EMA, Health Canada, PMDA, TGA, and MFDS jurisdictions • Preferred: Experience leading enterprise-level FDA remediation programs involving multiple facilities, product lines, and compliance workstreams

🏖️ 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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