Job Summary

• You will be responsible for providing regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally.
• 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.
• 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 a 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
• Strong communication skills in English

Work Rights