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

Additional Location(s): US-MN-Arden Hills

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.


About the role:

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

Requisition ID: 628715

Minimum Salary: $137700

Maximum Salary: $261600

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at and follow us on LinkedIn.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.