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 Director, Regulatory Affairs – Pulsed Field Ablation (PFA), provides strategic regulatory leadership for Boston Scientific’s PFA portfolio, one of the company’s most strategically critical and fastest-growing segments within Electrophysiology.

In this role, you will set the global regulatory vision and strategy for the PFA portfolio, providing leadership and direction across new product development, sustaining activities, global expansion and compliance initiatives. You will serve as a senior regulatory leader and key advisor to business and functional leadership, guiding complex regulatory decisions, anticipating emerging risks and opportunities, and driving alignment on regulatory priorities that enable business and portfolio objectives.

You will partner closely with leaders across R&D, clinical, quality, medical safety, operations, program management, and global and regional regulatory teams to shape portfolio strategy, influence critical business decisions and enable successful execution across an increasingly complex global regulatory environment.

This role has accountability for regulatory strategy and outcomes across the rapidly expanding PFA portfolio and leads and develops a high-performing regulatory organization. The Director will establish priorities, build organizational capability and ensure the regulatory function is positioned to deliver predictable, high-quality outcomes that support continued innovation, global growth and patient access.

Your responsibilities will include:

Regulatory strategy and execution:

● Set and lead global regulatory strategy for the PFA portfolio across the product life cycle, including development, clinical, submission, approval, launch, sustaining and global expansion.

● Provide strategic oversight of global regulatory applications and documentation, including 510(k), PMA, IDE, EU MDR/CE mark, supplements, reports and international registrations, as applicable, ensuring high-quality and predictable regulatory outcomes.

● Provide senior regulatory leadership on clinical strategies and regulatory positioning for PFA clinical programs, next-generation technologies and other strategic portfolio initiatives.

● Establish regulatory pathways and provide technical, clinical and strategic regulatory guidance for complex or high-impact programs and business decisions.

● Anticipate and assess regulatory risks, opportunities, timeline impacts and strategic trade-offs, providing recommendations and influencing decisions with business and functional leadership.

● Provide strategic oversight of significant regulatory submissions and deliverables, ensuring quality, consistency and alignment with portfolio and business objectives.

Leadership:

● Serve as the senior regulatory leader for the PFA portfolio, providing strategic direction and regulatory leadership on critical issues, escalations and cross-functional decisions.

● Establish organizational and portfolio priorities, allocate regulatory resources, and ensure appropriate capabilities are in place to support business objectives and deliver against the evolving needs of the PFA portfolio.

● Recruit, lead, develop and retain regulatory managers and senior individual contributors, fostering a high-performing organization and culture of accountability, collaboration and regulatory excellence.

● Build leadership depth, succession capability and regulatory expertise to support the continued growth and complexity of the PFA portfolio.

● Provide leadership through organizational, portfolio and regulatory change, ensuring the regulatory organization is positioned to anticipate and respond effectively to evolving business and regulatory needs.

● Shape and contribute to broader Electrophysiology Regulatory Affairs strategy, organizational priorities, capability building and functional excellence initiatives.

Internal and external stakeholder collaboration:

● Serve as a strategic regulatory advisor to business and functional leadership, ensuring regulatory considerations, risks and opportunities are integrated into portfolio, product and business decisions.

● Drive strategic alignment across global and regional teams, key sites and cross-functional partners supporting the PFA portfolio.

● Lead significant and complex interactions with FDA, notified bodies, competent authorities and other regulatory agencies, representing Boston Scientific and advocating for regulatory strategies that support portfolio objectives and patient access.

Compliance and process improvement:

● Provide senior regulatory leadership for audits, inspections, post-market issues, field actions and other significant compliance activities.

● Champion regulatory excellence, best practices and process improvements that strengthen regulatory capabilities, consistency and execution across the organization.

● 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 life cycle 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: 634472

Minimum Salary: $155000 

Maximum Salary: $294500 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will 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 www.bostonscientific.com 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.