Associate Director, Regulatory Affairs - Pulsed Field Ablation (PFA)
Core
Leading global regulatory strategy and execution for Boston Scientific's Pulsed Field Ablation (PFA) portfolio, the company's most strategically critical segment within Electrophysiology.
Role type
Senior leadership regulatory affairs manager (medical devices)
Builds
Global regulatory applications (510(k), PMA, EU MDR/CE mark) and clinical strategies for PFA products
Domain
Medical device industry, Electrophysiology, Cardiovascular devices
Deliverable
client delivery
Required skills
Global regulatory strategy, lifecycle management, submission preparation, health authority interaction, team leadership, risk assessment, cross-functional collaboration
Preferred skills
Electrophysiology domain expertise, audit/inspection management, complex portfolio management
Technologies
510(k), PMA, IDE, EU MDR, CE mark
Responsibilities
Define and execute regulatory strategies across the product lifecycle; oversee preparation and submission of global regulatory applications; provide technical and strategic regulatory guidance; lead and mentor a team of regulatory managers; drive collaboration with cross-functional stakeholders and regulatory agencies; support audits, inspections, and post-market compliance activities
Seniority
Director, hands-on leadership with people management