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Darshita Chauhan

Darshita Chauhan

Regulatory Affairs Associate

Pharmaceutical / Bio-tech

Toronto, Ontario

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Services offered

Regulatory Affairs professional with a Master's in Regulatory Affairs and a Bachelor's degree in Microbiology. Knowledge of ISO 13485:2016, CAPA, and USFDA requirements. Skilled in regulatory compliance, audits, and submission preparation. Certified in Internal Auditor for ISO 13485:2016, Good Clinical Practice and Medical and Food Microbiology. Committed to ensuring quality assurance and compliance with GxP standards.

Compliance specialist
Quality assurance
Regulatory affairs
Internal auditor
Approximate rate: CAD$ 25 per hour

Experience

AI-Enhanced SaMD : Regulatory Compliance, Market Analysis, and Submission Pathway Development

  • Supported the Medic Copilot project, leveraging AI technologies to enhance medical care in challenging environments.
  • Conducted research on Software as a Medical Device (SaMD) for diagnostics, ensuring regulatory compliance and product development.
  • Collaborated on defining software features and user interface elements to optimize diagnostic recommendations.
  • Conducted market surveys and analyzed approval processes for Medic Copilot in comparison to USFDA-approved SaMD.
  • Provided expertise on AI algorithms for diagnostic recommendations and contributed to submission pathway development.
  • Managed documentation drafting and refinement for regulatory approval, ensuring compliance and professionalism.
  • Overcame challenges in device classification and regulatory pathway identification through research and adaptive strategies.

Education

Northeastern University - Toronto

Master of Science (M.S) - Regulatory Affairs 

 Major - Majors: Drugs, Biologics & Medice device

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