Regulatory Affairs & Device Quality Systems Director

Job Purpose: The Director, Regulatory Affairs and Device Quality Systems provides strategic and operational leadership for all regulatory and device-quality activities across Nephron’s manufacturing divisions and affiliated entities. The role ensures end-to-end regulatory compliance, post-market vigilance, labeling governance, licensing maintenance, and quality-system oversight for medical devices and combination products. It specifically encompasses regulatory and device/combination-product quality-system compliance under 21 CFR Part 820 (Quality Management System Regulation, QMSR) and Part 4 (Combination Products), ISO 13485, and ISO 14971, while excluding direct oversight of drug-product cGMP quality systems (21 CFR Parts 210 and 211). Essential Duties and Responsibilities: Develop and communicate regulatory and device-quality strategies aligned with corporate objectives, risk tolerance, and product-portfolio growth plans Lead U.S. and international regulatory strategy for drug, device, and combination-product portfolios (ANDA, 510(k), EUA, 503B, supplements, annual reports). Oversee end-to-end management of regulatory submissions and dossiers, including ANDA and 503B applications, 510(k) notifications, and post-approval supplements (CBE-0, CBE-30, PAS), ensuring complete, accurate, and timely filings, deficiency responses, and annual report maintenance in accordance with FDA commitments. Serve as liaison to FDA and other health authorities, ensuring inspection readiness and timely responses to findings. Direct regulatory risk assessments, change-control impact evaluations, Field Alert Reports (FARs), recalls, and market-action decisions. Oversee device quality systems including design control, DHFs/DMRs, RMFs, risk management (ISO 14971), CAPA, and complaint investigations; ensuring ongoing alignment with evolving FDA Quality Management System Regulation (QMSR) and related ISO 13485 requirements. Lead labeling strategy and compliance governance across Rx, OTC, 503B, and device products, including Structured Product Labeling (SPL) submissions, content management, and change-control oversight to ensure accuracy, consistency, and regulatory alignment throughout the product lifecycle. Direct pharmacovigilance and post-market safety activities, ensuring compliance with 21 CFR 314.80 and 803 requirements, including ADE, MDR, PADER, and MedWatch reporting, trend analysis, and cross-functional escalation of safety signals. Oversee licensing and establishment registrations (GDUFA, MDUFA, OMUFA, 503B) and ensure renewals occur on time to maintain market access. Maintain product listing and periodic regulatory reporting for drug, device, and 503B products, including Structured Product Labeling (SPL) listings, 503B semi-annual reports, CARES Act drug-shortage reporting, and maintenance of accurate NDC, FEI, and product-code data across FDA systems. Manage product registration and market-access submissions for domestic and international markets, including End User Letters (EUL), import/export registrations, and related agency correspondence. Provide cross-departmental regulatory support to Quality Assurance, Operations, Supply Chain, R&D, and Business Development, ensuring regulatory alignment across product development, manufacturing changes, and commercial activities. Establish and monitor KPIs (submission timeliness, CAPA effectiveness, audit readiness, licensing renewals) and provide executive dashboards and Management Review inputs. Provide strategic input during business development, due diligence, and partnership evaluations regarding regulatory and quality-system maturity. Mentor and develop regulatory and device-quality staff; serve as SME during inspections, audits, and due diligence. Ensure governance and data integrity across regulatory and device-quality systems, including electronic submission, document control, and post market reporting platforms. While on-site presence is preferred, a hybrid work arrangement may b…

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