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Monika Bhatt, LL.M, RAC

Chief Regulatory Healthcare Counsel
Siemens Healthineers

Monika Bhatt
Chief FDA and Healthcare Regulatory Compliance Counsel at Siemens Healthineers (North America)

Monika Bhatt has over 20 years of experience advising clients on a broad range of FDA healthcare regulatory compliance and business issues, including market access, pre-market strategy, post-market compliance, Medical Device Reporting (MDR), product recalls, Quality System Regulations (QSR), establishment registration and device listing, labeling and promotion, import/export compliance, clinical trials, M&A Regulatory due diligence, FDA inspections and enforcement actions. Having represented both large multinational corporations and small startups on corporate and transactional matters, government enforcement investigations, compliance program design and implementation, she has a broad knowledge of regulatory and business issues impacting health and life science companies. Monika has written and spoken extensively on various aspects of FDA regulation of medical devices. She is Healthcare Compliance Certified and Regulatory Affairs Certified (RAC).

Disclosure information not submitted.

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