
Director Regulatory Affairs
7 days ago
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.
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