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

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

Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.

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:

• Regulatory strategy and execution:
• 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