Director Regulatory Affairs

About Our Client

Fast growing medical AI company developing cutting edge solutions that enhance patient outcomes.

Job Description

Manage regulatory submissions, lead a team, ensure product compliance, and strategically navigate global market entry. Success is measured by achieving and maintaining regulatory excellence, aligning cross-functional teams, and ensuring efficient product approvals.

The Successful Applicant

• Deep knowledge of AI regulations, Software as a Medical Device (SaMD), global regulatory frameworks like FDA, EU MDR, cybersecurity, and quality standards.
• 8-15 years work experience with hands on experience in AI and healthcare regulations
• Strategic thinking with the ability to align regulatory needs with portfolio opportunities.