Brad Roskoph

About Brad Roskoph

Senior Quality & Regulatory Affairs leader with proven success guiding medical device organizations through FDA, EU MDR, ISO 13485, and global regulatory requirements. I specialize in building regulatory strategies, leading market entry initiatives, and strengthening QMS frameworks that consistently withstand audits and inspections.I partner with executives and cross-functional teams to align compliance with business objectives, accelerate global submissions, and drive continuous improvement. Passionate about advancing patient safety and innovation, I focus on shaping a culture of quality, mentoring teams, and delivering sustainable results in highly regulated environments.

Experience

1. Vice President of Quality, Regulatory, and Manufacturing

   Xperience Robotics Inc. Dba. Ugen

   Aug 2025 — Present

Education

• Cleveland State University

  Master’s Degree, Engineering

• Cleveland Clinic EMS Academy

  EMT-B Certification, Emergency Medical Technology/Technician (EMT Basic)

• Cuyahoga Community College

  Continuing Education, Biological and Biomedical Sciences

• Cornell University

  Certification, Project Management

• Ohio University

  Bachelor of Science (B.S.), Physiology of Exercise

Skills

• 3d Modeling
• Quality Control
• Project Management
• Product Design
• Rehabilitation
• Fitness
• Additive Manufacturing
• Social Networking
• Sports Medicine
• Emergency Medicine
• Hospitals
• Orthopedic
• Solidworks
• Nutrition
• Pediatrics
• Public Speaking
• Teaching
• First Aid
• Health Education
• Leadership
• Exercise Physiology
• Matlab
• Clinical Research
• Powerpoint
• Microsoft Excel
• Biomechanics
• Microsoft Office
• Ekg
• Medical Imaging
• Medical Devices
• Management
• Cpr Certified
• Medicine
• Data Analysis
• Research
• Microsoft Word
• Healthcare
• 510k Review and Generation
• Cyber-Security Protocols
• Capas and Scars