Devanshi Doshi Email & Phone Number

I am a highly skilled Regulatory Affairs professional with over 4 years of experience across pharmaceuticals, medical devices, and nutritional products. I have a proven track record of supporting global regulatory submissions and compliance, ensuring adherence to stringent regulatory standards for diverse markets including the US, EU, LATAM, MENAP, CADR, and EURI.Currently, I am a Regulatory Affairs Associate at Abbott, where I manage regulatory submissions for food products, FSMP, enteral nutrition, IF & FUF, and pharmaceuticals across global markets, including EURI, MENAP, and LATAM. Using the Veeva System, I compile, submit, and track regulatory documentation, ensuring compliance with international standards. I handle critical documents like COFS, BOM100%, COA, LOA, stability reports, QQ data, and clinical information. I also prepare dossiers for various markets, including Israel, and contribute to global initiatives such as the CODEX standards revision for CADR countries and LATAM nutrition projects. Additionally, I manage deficiency processes for AN product submissions to ensure compliance.Previously, I gained extensive experience at Intuvie and Nova Biomedical, where I was involved in FDA 510(k) submissions, IVDR compliance, UDI registrations, and supporting international regulatory submissions for diagnostic devices and medical equipment. Additionally, I played an integral role in internal and external quality system audits and contributed to the preparation of regulatory and quality system documentation for product registration.At Meteoric Biopharmaceutical Pvt. Ltd, I worked on business development and regulatory affairs, overseeing the registration process for enzymes, probiotics, and nutraceuticals in international markets. I also led product development meetings, created regulatory strategies, and ensured compliance for various regulatory agencies including FSSAI, US FDA, and Health Canada.With a strong background in regulatory strategy, dossier preparation, deficiency management, and cross-functional collaboration, I excel at navigating complex regulatory landscapes to drive efficient market access. Passionate about regulatory affairs, I am committed to ensuring the safe and effective delivery of healthcare products. Always eager to expand my knowledge and stay updated on industry trends, I aim to contribute to the success of innovative healthcare solutions and make a meaningful impact in the regulatory field.