Director Regulatory Affairs

7 days ago


Borivli, Maharashtra, India Michael Page Full time
Be part of fastest growing medical AI company success storyBe the primary liaison for quality system management and 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.



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