Vedanshi is an experienced regulatory affairs professional with extensive experience as a Regulatory affairs officer at the Medical Devices Directorate of Health Canada. Vedanshi has hands-on experience with regulatory submission for Class I to IV medical device applications and amendments, including product labels, test reports, application forms, and ISO 13485/ MDSAP certificates under the Interim Order and Medical Device Regulations. Over the years of experience at the Medical Device Directorate, Vedanshi has gained expertise in the interpretation and application of the US FDA and Health Canada regulations and regulatory requirements for the medical devices industry. Vedanshi also has experience in project management and stakeholder communication, including communications with Health Authorities and the industry. Vedanshi has hands-on expertise with Health Canada Food and Drugs Regulations, GMP, GDP, GCP, and ICH guidelines.
Additionally, Vedanshi is a Quality professional with experience in Quality Compliance and Quality systems, including technical writing of controlled documents such as SOPs, IWIs, guidelines, etc. Vedanshi has in-depth knowledge and experience in both Regulatory and Quality roles.
Vedanshi has a Bachelor of Science from the University of Toronto and a Post-Graduate Diploma in Pharmaceutical Regulatory Affairs and Quality Operations Program from Seneca College