Rucha Patel

Quality Assurance and Regulatory Affairs Manager, MIMOSA Diagnostics Inc.

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Ms. Rucha Patel is an experienced Quality Assurance and Regulatory Affairs Professional with over 07 years of strong Regulatory Compliance and Regulatory Submission experience with exposure in start-up, small and large businesses in compliance with US FDA, Health Canada, European Union, ISO 13485:2016, ISO 9001:2015, 21 CFR Part 820, 21 CFR Part 11, MDSAP, GMP, GCP, GLP, and ICH Guidelines requirements. Through her strategic thinking and risk-based approach, she has been able to develop effective Quality Systems within the Clinical Trial, Pharmaceutical and Medical Device Industries.