Senior Director – Regulatory Intelligence, FDA Engagement

Vaga não está no LinkedIn

🕒 6 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $203.000 - $305.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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Medline Industries, LP

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1910

🏥 Saúde

📦 Logística

🏭 Manufatura

💰 Private Equity Round em 2021-06

Healthcare • Logistics • Manufacturing

A Medline Industries, LP é uma empresa líder em saúde que se concentra em melhorar os resultados clínicos, financeiros e operacionais de seus clientes. A empresa oferece uma ampla gama de mais de 335. 000 produtos médicos e possui capacidades extensas de armazenamento com mais de 28 milhões de pés quadrados. Com uma presença global significativa de 43. 000 funcionários, a Medline fornece soluções ágeis e escaláveis em todos os pontos de atendimento, alcançando uma taxa de entrega no dia seguinte de 95% dentro dos EUA. A missão da empresa é aprimorar a prestação de cuidados de saúde fornecendo produtos superiores, resiliência na cadeia de suprimentos e expertise clínica, além de fomentar fortes relações com os clientes por meio de soluções personalizadas e resolutivas.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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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