Senior Regulatory Affairs Specialist - SEISMIQ
Core
Senior Regulatory Affairs Specialist supporting an innovative intravascular lithotripsy system (SEISMIQ) console portfolio, focusing on capital equipment, embedded software, electrical, optical, and cybersecurity compliance.
Role type
Senior Regulatory Affairs Specialist (Medical Devices)
Builds
Global regulatory approvals and compliance for the SEISMIQ console portfolio
Domain
Medical Devices / Cardiovascular / Capital Equipment
Required skills
Regulatory strategy development, submission preparation (510(k), PMA, EU MDR), change assessment, cross-functional partnership, technical writing, project management, risk management, audit support
Preferred skills
Advanced degree in related discipline, experience with energy-delivery devices or software-enabled medical devices
Technologies
Microsoft Word, Excel, PowerPoint, Adobe Acrobat
Responsibilities
Develop and implement U.S., EU, and international regulatory strategies for new and modified console products; Prepare, coordinate, author, and maintain regulatory submissions and supporting documentation; Serve as the Regulatory Affairs representative on cross-functional console development and sustaining teams; Assess console product, software, cybersecurity, electrical, optical, mechanical, supplier, manufacturing, and service changes for regulatory impact; Partner with Systems, Software, Electrical, Mechanical, Human Factors, Cybersecurity, Design Assurance, Quality, Clinical, Medical Safety, Operations, Service, and international regulatory teams; Review console design and technical documentation for regulatory readiness; Develop and maintain productive working relationships with FDA, EU Notified Body, and other regulatory reviewers; Coordinate with international regulatory partners to communicate console-specific requirements; Support regulatory audits and inspections; Apply sound project management, prioritization, and technical writing skills to manage multiple regulatory deliverables; Maintain a primary commitment to patient safety and product quality
Seniority
Senior, hands-on IC