Associate Director, Regulatory Affairs - Pulsed Field Ablation (PFA)

Associate Director, Regulatory Affairs – Pulsed Field Ablation (PFA) Location: Arden Hills, MN, 55112 The Associate Director, Regulatory Affairs – Pulsed Field Ablation (PFA) is responsible for leading global regulatory strategy and execution for Boston Scientific’s Pulsed Field Ablation portfolio, the company’s most strategically critical and fastest‑growing segment within Electrophysiology. In this role, you will provide strategic regulatory leadership and serve as the primary regulatory point of contact for PFA strategy, escalations, and program‑level decision‑making across new products, sustaining activities, global expansion, and compliance initiatives. You will partner closely with R&D, clinical, quality, medical safety, operations, program management, and global and regional regulatory teams to support business objectives. This role owns regulatory decision‑making for a rapidly expanding and increasingly complex PFA portfolio and leads a high‑performing regulatory team to deliver predictable, high‑quality regulatory outcomes worldwide. Your responsibilities will include: Define and execute regulatory strategies for the PFA portfolio across the product lifecycle, including development, clinical, submission, approval, launch, sustaining, and global expansion. Oversee preparation and submission of global regulatory applications and documentation, including 510(k), PMA, IDE, EU MDR/CE mark, supplements, reports, and international registrations, as applicable. Provide regulatory leadership on clinical strategies and regulatory positioning for PFA clinical programs and next‑generation initiatives. Provide technical, clinical, and strategic regulatory guidance during strategy development, submission preparation, and regulatory pathway planning. Assess regulatory risks, timeline impacts, and decision trade‑offs, and provide recommendations to business and functional leadership. Review and edit submissions and other regulatory deliverables prepared by team members. Leadership: Serve as the primary regulatory owner for the PFA portfolio, providing direction on key issues, escalations, and cross‑functional decisions. Provide day‑to‑day leadership, prioritization, mentoring, and escalation support for regulatory managers and team members. Establish project priorities, allocate workload, and ensure appropriate regulatory support across the portfolio. Lead, develop, and mentor a team of regulatory managers and senior individual contributors. Build leadership depth, succession capability, and regulatory excellence within the PFA regulatory organization. Support broader electrophysiology regulatory affairs initiatives, including organizational priorities, capability building, and process improvements. Internal and external stakeholder collaboration: Drive collaboration and alignment with cross‑functional stakeholders to integrate regulatory considerations into product and business decisions. Coordinate strategic alignment across key sites and partners supporting PFA execution. Lead strategic interactions with FDA, notified bodies, competent authorities, and other regulatory agencies. Compliance and process improvement: Provide regulatory support for audits, inspections, post‑market issues, field actions, and other compliance activities. Contribute to development of best practices, process improvements, and broader regulatory affairs initiatives. Support and maintain quality initiatives in accordance with Boston Scientific quality policy and applicable procedures. Qualifications: Required qualifications: Bachelor’s degree required or equivalent combination of education and experience. Minimum of 12 years’ experience in regulatory affairs or a combination of regulatory affairs and closely related functions within the regulated medical device industry, including clinical or quality. Minimum of 5 years’ experience in people management, including leadership of managers, senior regulatory professionals, or both. Demonstrated experience leading global regulatory strategy and execution for complex medical device portfolios. Extensive experience with regulatory submissions and lifecycle management, including 510(k), IDE, PMA, EU MDR/CE mark, and international registrations. Proven track record of direct health authority interactions, including leading or supporting regulatory agency meetings and submissions. Experience managing multiple concurrent regulatory programs or submissions with competing timelines and priorities. Preferred qualifications: Advanced degree, including MS, PhD, JD, or equivalent. Prior experience in electrophysiology, ablation, cardiovascular devices, or catheter‑based technologies. Experience supporting integrated portfolios involving disposables, capital equipment, system‑level changes, and clinical evidence strategies. Experience supporting audits, inspections, post‑market issues, and sustaining activities. Strong communication, collaboration, organizational, and influencing skills. Demonstrated ability to operate effectively in complex, fast‑paced, and ambiguous environments. Requisition ID: 628715 Minimum Salary: $137,700 Maximum Salary: $261,600 Boston Scientific is an equal opportunity employer. All employment decisions are made in compliance with the equal employment opportunity policy covering race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity or expression, veteran status, age, mental or physical disability, and genetic information. Eligible candidates for U.S. based positions may be required to provide acceptable proof of COVID‑19 vaccination status in accordance with applicable law. #J-18808-Ljbffr