Principal Consultant / Director of Regulatory Affairs / VP of Quality
A distinguished Chief Regulatory & Quality Strategist and VP, Global Regulatory Affairs, with over 20 years of dedicated expertise in navigating the complex global regulatory landscape for medical devices and IVDs. Amir possesses a remarkable track record of success in securing market access and ensuring compliance across stringent regulatory bodies including the FDA, EU MDR, UKCA, and Asia-Pacifi...
Experience: 17+ years
Submissions: 14 510(k), 8 PMA
AMIR PANAH provides regulatory consulting services to clients in:
Possesses a Bachelor of Engineering in Mechanical Engineering from Mohawk College, providing a strong technical foundation crucial for understanding complex medical devices. This engineering background is augmented by continuous professional development, ensuring a deep grasp of both the technical and regulatory aspects of medtech innovation. This combination of formal engineering education and specialized regulatory knowledge equips them to effectively bridge the gap between product development and market compliance.
A seasoned regulatory affairs executive with over 20 years of experience leading global market access and compliance for Class II/III medical devices and IVDs. Proven success in building and scaling regulatory frameworks across FDA, EU MDR, UKCA, and APAC markets, including advising on high-stakes FDA interactions and M&A due diligence. Career highlights include directing global regulatory strategy for 30+ firms, achieving over 50 regulatory approvals across 10+ jurisdictions, and enabling over $500M in cumulative market access. Expertise spans various senior roles, including VP of Quality and Director of Regulatory Affairs, demonstrating a comprehensive understanding of the regulatory lifecycle. Their extensive consulting engagements with numerous medtech companies underscore their adaptability and proven ability to deliver results.
A distinguished Chief Regulatory & Quality Strategist and VP, Global Regulatory Affairs, with over 20 years of dedicated expertise in navigating the complex global regulatory landscape for medical devices and IVDs. Amir possesses a remarkable track record of success in securing market access and ens...
With over 20 years of dedicated experience, Amir Panah is a distinguished regulatory and quality strategist for medtech companies, boasting a profound understanding of complex global regulatory landscapes. His extensive track record includes securing market access and ensuring compliance across stringent bodies like the FDA, EU MDR, and UKCA, making him an invaluable asset for navigating high-stakes FDA interactions and M&A due diligence. Amir's expertise extends to cutting-edge areas such as Software as a Medical Device (SaMD) and AI/ML technologies, positioning him as a leader in emerging regulatory frontiers. His proven success in achieving over 50 regulatory approvals across more than 10 jurisdictions, coupled with a deep technical foundation from his engineering background, allows him to effectively bridge product development with market compliance, driving strategic growth for medtech organizations.
This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.
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