Snehal Babar

• Assessed 21 CFR Part 11 compliance for electronic systems.
• Supported medical device companies in EU MDR transitions.
• Conducted gap analyses and supported technical documentation

• Facilitated engagement initiatives to strengthen community relationships and participation.
• Organized and facilitated educational workshops for local families and children.
• Organized and scheduled volunteer shifts to ensure smooth event operations.

• Drafted FDA Pre-Submission documents for Class II medical device.
• Authored hemocompatibility study reports per FDA requirements.

• Conducted GMP vendor audits and qualifications.
• Maintained traceability in sample handling and documentation.
• Authored quality procedures to align with FDA standards.

• Lead food safety and sanitation programs in compliance with HACCP, USDA, and FDA standards.
• Review and approve batch records, ensuring data accuracy for regulatory readiness.
• Represent QA during FDA and regulatory audits; manage documentation and queries.
• Oversee OOS management, deviation investigations, and change controls.
• Conducted GMP vendor audits and qualifications.
• Maintained traceability in sample handling and documentation.
• Authored quality procedures to align with FDA standards.
• Assessed 21 CFR Part 11 compliance for electronic systems.
• Supported medical device companies in EU MDR transitions.
• Conducted gap analyses and supported technical documentation.
• Led FDA QSR and EU MDR-compliant audits and inspections.
• Coordinated CAPA implementation and regulatory submissions.
• Assisted in ISO 13485-compliant submissions.
• Contributed to risk management and documentation enhancement.
• Drafted FDA Pre-Submission documents for Class II medical device.
• Authored hemocompatibility study reports per FDA requirements.

• Managed inventory and prescription documentation to ensure compliance.
• Maintained accurate inventory of pharmaceutical supplies and products.
• Provided exceptional customer service by answering patient inquiries.

• Assisted in ISO 13485-compliant submissions.
• Contributed to risk management and documentation enhancement.

• Assisted in preparing regulatory submissions for medical devices and pharmaceuticals.

• Lead food safety and sanitation programs in compliance with HACCP, USDA, and FDA standards.
• Review and approve batch records, ensuring data accuracy for regulatory readiness.
• Represent QA during FDA and regulatory audits; manage documentation and queries.
• Oversee OOS management, deviation investigations, and change controls.