Job Summary

• Provide regulatory leadership and strategic direction for Ultrasound regulatory AI Software programs, including global RA support for registration planning, submissions, notified body and quality system audits, and program implementation across a cross-functional team with communication to leadership.
• Develop regulatory strategies to help optimize regulatory submission pathways, taking into consideration regulatory requirements (including product testing, clinical data, etc), product claims and country regulatory dependencies to ensure optimized sequencing for submissions.
• Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities.

Matching Summary

Skills & Requirements

Key Requirements

• Proven experience in regulated field, especially AI software
• Advanced practical experience in Quality & Regulatory Affairs
• Bachelor's degree in software engineering, regulatory affairs or equivalent
• Strong oral and written communication skills
• Demonstrated ability to analyze and resolve problems
• Ability to document, plan, market, and execute programs
• Established project management skills

Work Rights