Additional Location(s): US-MN-Maple Grove

About the role:

As a Fellow, Regulatory Affairs supporting the Intravascular Lithotripsy (IVL) franchise within Interventional Cardiology Therapies (ICVT), you will serve as a senior individual contributor and regulatory strategy leader for the SEISMIQ product platform and related complex, clinically driven device programs. You will develop, influence and execute global regulatory strategies to obtain and maintain market approvals throughout the product life cycle while partnering closely with Clinical, Research and Development, Quality, Operations, Franchise, Integration and regional Regulatory Affairs leaders.

This role requires extensive FDA-facing experience, the ability to navigate evolving priorities across dual quality systems during acquisition integration, and the leadership skills to influence complex cross-functional initiatives. Reporting to the Senior Director, Regulatory Affairs, you will help shape regulatory strategy for innovative technologies that improve patient outcomes around the world.

Work model, sponsorship:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:
• Lead the development, alignment and execution of global regulatory strategies to obtain and maintain approvals for the IVL franchise, including the SEISMIQ product platform and related product life cycle programs.
• Serve as the senior Regulatory Affairs representative on complex product development, clinical evidence, sustaining engineering and commercial expansion initiatives by translating clinical, technical, design, labeling, software, systems and manufacturing considerations into clear regulatory strategies.
• Independently assess the regulatory impact of product, labeling, design, manufacturing, supplier, site and quality system changes, and determine appropriate submission, notification, registration and approval maintenance pathways.
• Prepare, review and direct regulatory submissions and health authority communications, including PMA and IDE supplements, annual reports, 30-day notices, Pre-Submissions, deficiency responses, 510(k) submissions, EU MDR and Notified Body submissions, and global registration activities, as applicable.
• Lead and support direct interactions with the U.S. Food and Drug Administration (FDA) and other global health authorities, including meeting strategy, briefing materials, agency responses, negotiation of regulatory expectations and execution of post-meeting commitments.
• Partner with Regulatory Affairs leadership, integration teams, Quality, Clinical, Research and Development, Operations, Marketing and regional Regulatory Affairs teams to align regulatory strategies with business objectives and resolve issues arising from differing processes, priorities and quality systems.
• Identify and communicate regulatory risks, dependencies and trade-offs while developing practical mitigation strategies that protect compliance, patient safety and business objectives.
• Provide regulatory leadership, coaching and technical guidance to Regulatory Affairs colleagues and cross-functional partners, strengthening organizational capability in IVL technologies, complex medical devices, clinical evidence and global regulatory strategy.
• Support acquisition integration activities, including regulatory process integration, inspection readiness, legal manufacturer and site transfer activities, and coordination of regulatory information across quality systems while maintaining focus on product approvals and product life cycle management.
• Travel up to 20% to support project team collaboration, Boston Scientific and acquisition-transition sites, health authority meetings, inspections, audits and physician, customer or clinical learning activities, as business needs require.

Qualifications:

Required qualifications:
• Minimum of a bachelor's degree in engineering, life sciences, regulatory affairs or a related discipline.
• Minimum of 10 years' experience in Regulatory Affairs or a related discipline, including Quality, Research and Development, Clinical or Post Market, within the medical device, in vitro diagnostics (IVD), pharmaceutical or broader health care industries.
• Demonstrated experience developing and executing regulatory strategies for complex medical devices, including U.S. Class III PMA and IDE programs.
• Demonstrated experience leading cross-functional regulatory strategy for complex product development programs from development through commercialization.
• Demonstrated experience preparing and leading regulatory submissions and approval maintenance activities throughout the product life cycle.
• Prior experience interacting directly with the U.S. Food and Drug Administration (FDA) or other regulatory authorities, including regulatory meetings, deficiency responses and negotiation of submission requirements.
• Demonstrated ability to interpret complex clinical, technical, design, manufacturing and quality system information and translate it into regulatory assessments, strategic recommendations and risk-based decisions.
• Demonstrated ability to communicate and influence senior leaders, cross-functional teams, regional Regulatory Affairs organizations and external regulatory agencies.
• Ability to travel up to 20%, including occasional overnight travel.

Preferred qualifications:
• Advanced degree (M.S., Ph.D., Pharm.D., J.D. or equivalent) in engineering, life sciences, regulatory affairs or a related discipline.
• Experience supporting intravascular lithotripsy, interventional cardiology, catheter-based therapies, electromechanical or system-based medical devices, or other complex Class III technologies.
• Experience with SEISMIQ or similar console- and catheter-based technologies, including clinical evidence, software, electrical safety, electromagnetic compatibility (EMC), cybersecurity, sterilization, biocompatibility and human factors engineering.
• Experience working in acquisition integration, dual quality management system environments, legal manufacturer transitions, site transfers or process integration initiatives.
• Experience with global regulatory pathways and approval maintenance, including EU MDR and Notified Body submissions and regulatory submissions in Japan, China or other key international markets.
• Demonstrated ability to work independently in ambiguous environments, balance competing priorities and develop practical regulatory solutions across organizations with differing processes and conventions.
• Regulatory Affairs Certification (RAC) in Medical Devices and/or U.S. FundamentaTop of FormBottom of Formls.

#lLI-Hybrid

Requisition ID: 631195

Minimum Salary: $125800

Maximum Salary: $239000

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.