Description
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 be available depending on the candidate's experience and qualifications. Candidates should expect to be on-site for inspections, audits, and leadership meetings regardless of work arrangement.
Job Specifications and Qualifications:
Knowledge & Skills:
- Proven experience leading ANDA, 510(k), and 503B submissions; direct FDA/ISO audit participation.
- Comprehensive understanding of 21 CFR Parts 4, 210/211, 820 (QMSR), ISO 13485, and 14971.
- Strong technical writing, analytical, and root-cause-investigation skills.
- Ability to translate regulatory requirements into actionable business processes and procedures.
- Leadership presence with the capacity to influence cross-functional teams and executive stakeholders.
- Exceptional organization, prioritization, and decision-making in fast-paced environments.
Education/Experience:
- Doctorate-level candidates (PharmD, PhD, or equivalent): Typically, 7 years of pharmaceutical or medical-device industry experience, including 5 or more years of demonstrated capabilities in Regulatory Affairs or Quality Systems leadership.
- Master's or Bachelor's-level candidates: Typically, 12 years of industry experience with 7 or more years of direct Regulatory Affairs or Device Quality Systems responsibility.
- Equivalent combinations of advanced education, training, and demonstrated leadership may be considered.
Working Conditions / Physical Requirements:
- Standard business hours, with flexibility to meet company needs.
- Occasional travel for regulatory meetings or audits.