Regulatory Affairs Leader – AI Software Devices

This is a fully remote position, open to applicants in Germany.

📋 Description

• Provide leadership in regulatory affairs and strategic direction for Ultrasound regulatory AI Software programs.

• Ensure compliance with premarket submissions/registrations and maintain post-market adherence.

• Formulate regulatory strategies aimed at optimizing submission pathways.

• Leverage technical expertise and judgment to address and resolve issues.

• Evaluate modifications in existing products to ascertain the necessity for new or updated licenses or registrations.

• Review and authorize advertising and promotional materials to confirm alignment with approved claims and regulatory standards.

• Assist in the writing and editing of technical documentation.

• Conduct research, analyze, integrate, and organize background information from various sources for regulatory submissions.

• Implement regulatory requirements and comprehend their implications on submissions as well as pre- and post-market compliance.

⛳️ Requirements

• Demonstrated experience in a regulated environment, particularly in AI software.

• In-depth practical experience in Quality & Regulatory Affairs.

• Bachelor's degree in software engineering, regulatory affairs, or a related field.

• Exceptional oral and written communication abilities.

• Proven capacity to analyze and address problems effectively.

• Proficiency in documenting, planning, marketing, and executing programs.

• Well-established project management skills.

• Strong communication skills in English, both spoken and written.

🏝️ Benefits

• Commitment to inclusion and diversity.

• Equal Opportunity Employer.