Fellow, Regulatory Affairs

Location:

US-MN-Maple Grove

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.

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.

• 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.

• Minimum of a bachelor's degree in engineering, life sciences, regulatory affairs or a related discipline.
• Minimum of 10…