Devesh Kanekar

An extremely driven individual who graduated with a Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices at Northeastern University with a desire to have useful experience working in the pharmaceutical sector, to increase my understanding, knowledge, and expertise in relation to regulatory guidance and requirements.

• Coordinated the preparation of documents for regulatory submissions for an FDA regulated research & manufacturing procedures
• Assessed all materials required for submissions, license renewal, and annual registrations. Monitored and improved quality and regulatory systems
• Reviewed and revised departmental SOPs for regulatory compliance as appropriate as well-prepared General Safety and Performance requirements (GSPR) checklist by Annex I of EU MDR for the device
• Provided ideas for process development and trained new interns about device description and process management also observed changes and updates to regulatory practices

Masters in Regulatory Affairs for Drugs, Biologics, and Medical Deviecs