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

Additional Location(s): US-MN-Arden Hills\n\nDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance\n\nAt Boston Scientific, we\u2019ll give you the opportunity to harness all that\u2019s 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\u2019ll help you in advancing your skills and career. Here, you\u2019ll be supported in progressing \u2013 whatever your ambitions. \n\n \n\nAbout the role:\n\nBoston 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.\n\n \n\nThe Associate Director, Regulatory Affairs \u2013 Pulsed Field Ablation (PFA) is responsible for leading global regulatory strategy and execution for Boston Scientific\u2019s Pulsed Field Ablation portfolio, the company\u2019s most strategically critical and fastest-growing segment within Electrophysiology.\n\n \n\nIn 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.\n\n \n\nYou will partner closely with R\u0026D, clinical, quality, medical safety, operations, program management, and global and regional regulatory teams to support business objectives.\n\n \n\nThis 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.\n\n \n\nYour responsibilities will include:\n\n \n\nRegulatory strategy and execution:\n\n\u25cf Define and execute regulatory strategies for the PFA portfolio across the product lifecycle, including development, clinical, submission, approval, launch, sustaining, and global expansion\n\n\u25cf 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\n\n\u25cf Provide regulatory leadership on clinical strategies and regulatory positioning for PFA clinical programs and next-generation initiatives\n\n\u25cf Provide technical, clinical, and strategic regulatory guidance during strategy development, submission preparation, and regulatory pathway planning\n\n\u25cf Assess regulatory risks, timeline impacts, and decision trade-offs, and provide recommendations to business and functional leadership\n\n\u25cf Review and edit submissions and other regulatory deliverables prepared by team members\n\n \n\nLeadership:\n\n\u25cf Serve as the primary regulatory owner for the PFA portfolio, providing direction on key issues, escalations, and cross-functional decisions\n\n\u25cf Provide day-to-day leadership, prioritization, mentoring, and escalation support for regulatory managers and team members\n\n\u25cf Establish project priorities, allocate workload, and ensure appropriate regulatory support across the portfolio\n\n\u25cf Lead, develop, and mentor a team of regulatory managers and senior individual contributors\n\n\u25cf Build leadership depth, succession capability, and regulatory excellence within the PFA regulatory organization\n\n\u25cf Support broader electrophysiology regulatory affairs initiatives, including organizational priorities, capability building, and process improvements\n\n \n\nInternal and external stakeholder collaboration:\n\n\u25cf Drive collaboration and alignment with cross-functional stakeholders to integrate regulatory considerations into product and business decisions\n\n\u25cf Coordinate strategic alignment across key sites and partners supporting PFA execution\n\n\u25cf Lead strategic interactions with FDA, notified bodies, competent authorities, and other regulatory agencies\n\n \n\nCompliance and process improvement:\n\n\u25cf Provide regulatory support for audits, inspections, post-market issues, field actions, and other compliance activities\n\n\u25cf Contribute to development of best practices, process improvements, and broader regulatory affairs initiatives\n\n\u25cf Support and maintain quality initiatives in accordance with Boston Scientific quality policy and applicable procedures\n\n \n\nQualifications:\n\n \n\nRequired qualifications:\n\n\u25cf Bachelor\u2019s degree required or equivalent combination of education and experience\n\n\u25cf Minimum of 12 years\u0027 experience in regulatory affairs or a combination of regulatory affairs and closely related functions within the regulated medical device industry, including clinical or quality\n\n\u25cf Minimum of 5 years\u0027 experience in people management, including leadership of managers, senior regulatory professionals, or both \n\n\u25cf Demonstrated experience leading global regulatory strategy and execution for complex medical device portfolios\n\n\u25cf Extensive experience with regulatory submissions and lifecycle management, including 510(k), IDE, PMA, EU MDR/CE mark, and international registrations\n\n\u25cf Proven track record of direct health authority interactions, including leading or supporting regulatory agency meetings and submissions\n\n\u25cf Experience managing multiple concurrent regulatory programs or submissions with competing timelines and priorities\n\n \n\nPreferred qualifications:\n\n\u25cf Advanced degree, including MS, PhD, JD, or equivalent\n\n\u25cf Prior experience in electrophysiology, ablation, cardiovascular devices, or catheter-based technologies\n\n\u25cf Experience supporting integrated portfolios involving disposables, capital equipment, system-level changes, and clinical evidence strategies\n\n\u25cf Experience supporting audits, inspections, post-market issues, and sustaining activities\n\n\u25cf Strong communication, collaboration, organizational, and influencing skills\n\n\u25cf Demonstrated ability to operate effectively in complex, fast-paced, and ambiguous environments\n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\nRequisition ID: 628715\n\nMinimum Salary: $137700\n\nMaximum Salary: $261600\n\nThe anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) \u2013 see www.bscbenefitsconnect.com\u2014will 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.\n\nCompensation 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).\n\nCompensation 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).\n\nFor MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.\n\nBoston 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.\n\nBoston 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.\n\nPlease 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\u2019s policies or protocols change with regard to COVID-19 vaccination.\n