Divya Lekkala Email & Phone Number

Tucson, Arizona, United States

Toronto, Ontario, Canada

Internship project in collaboration with Northeastern University Experiential Network (XN) and Crown College of Canada.Internship Supervisor: Professor Peivand Pirouzi, Ph.D.Preparation of submission documents to meet Health Canada's validation criteria and CTD submissions, ensuring full compliance with the Canadian and International regulatory standards.Interpretation and application of ICH-M4 guidelines, and Health Canada's regulations, guidance documents, and policies to… Show more Internship project in collaboration with Northeastern University Experiential Network (XN) and Crown College of Canada.Internship Supervisor: Professor Peivand Pirouzi, Ph.D.Preparation of submission documents to meet Health Canada's validation criteria and CTD submissions, ensuring full compliance with the Canadian and International regulatory standards.Interpretation and application of ICH-M4 guidelines, and Health Canada's regulations, guidance documents, and policies to effectively prepare, compile, and format regulatory documents in accordance with regulatory guidelines. Show less

Cambridge, Massachusetts, United States

Developed and implemented an automated reference linking capability and library within Veeva Vault, enhancing efficiency in managing advertising, labeling, promotional, scientific statements, and marketing claims.Collaborated with cross-functional teams to gather data and assess complaint communications for regulatory compliance, reportability, and potential impact to patient safety and business operation.

India

• Author for systematic literature review reports, clinical evaluation plan (CEP) and clinical evaluation reports (CER) for devices in compliance with MEDDEV 2.7/1 Rev.4 and EU MDR for CE making and approval. Prepared postmarket surveillance plans, post market surveillance reports (PMS), Periodic Safety Update Reports (PSUR) and post market clinical follow up (PMCF)documents for class II and Class III devices, per EU MDR and US FDA medical device regulations.• Review systematic… Show more • Author for systematic literature review reports, clinical evaluation plan (CEP) and clinical evaluation reports (CER) for devices in compliance with MEDDEV 2.7/1 Rev.4 and EU MDR for CE making and approval. Prepared postmarket surveillance plans, post market surveillance reports (PMS), Periodic Safety Update Reports (PSUR) and post market clinical follow up (PMCF)documents for class II and Class III devices, per EU MDR and US FDA medical device regulations.• Review systematic literature searches on PubMed, Cochrane, Prospero and Embase database. interpretation of clinical trial searches on EU Clinical Trials, US Clinical Trials, Cochrane Trials and WHO ICTRP websites. • Analysis of adverse event reports, recalls, field safety corrective actions and field safety notices on US FDA MAUDE, US FDA TPLC, MHRA, BfArM and Swissmedic databases. Prepared and facilitated 510(k), PMA, IDE submissions, ensuring adherence to regulatory guidelines and documentation requirements for timely product approval and market clearance.• Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables. Show less

Hyderabad, Telangana, India

Authored clinical evaluation protocols, CEPs, CERs by screening literature, clinical documentation, risk management and technical files and ensured data accuracy, consistency and compliance with EU IVDR.Reviewed and analyzed risk analysis documentation for authoring periodic safety update reports (PSUR), summary of safety and performance reports (SSCP) and post market clinical follow-up (PMCF) reports as a part of PMS activity.• Implemented change controls and raised change orders… Show more Authored clinical evaluation protocols, CEPs, CERs by screening literature, clinical documentation, risk management and technical files and ensured data accuracy, consistency and compliance with EU IVDR.Reviewed and analyzed risk analysis documentation for authoring periodic safety update reports (PSUR), summary of safety and performance reports (SSCP) and post market clinical follow-up (PMCF) reports as a part of PMS activity.• Implemented change controls and raised change orders within the Quality Management System (QMS), ensuring proper documentation and adherence to regulatory standards.• Spearheaded review activities for artworks, promotional material, labelling and advertising material ensuring accuracy and adherence to regulatory compliance.• Creation of change order and change awareness notification as per the variations raised to manufacturer products in E.U region as part of Global Labelling activities. • Update artworks to all the markets of European Union for all the manufacturer products according to EMA variations using Harmony Tool. • Ensure that all design and readability guidelines are adhered to across the full range of products. Show less

India

Conducted systematic literature searches and screening using PubMed, Cochrane, Embase and Google Scholar. Analyzed and collated clinical trial data from EU Clinical Trials, US Clinical Trials, & WHO ICTRP databases for medical devices.Ensured consistency, periodic updates, implementation of change order and change awareness notifications for artworks and conducted briefing, annotations, business approval steps using Artwork Management System.

Master Of Science - Ms, Regulatory Affairs, 3.9

Master'S In Pharmacy (M. Pharm), Pharmaceutical Sciences, 8.15 Cgpa

Pharmaceutical technology as specialization

Bachelor Of Pharmacy - Bpharm, Pharmacy, 83.15 Per Cent

School, 9.6 Cgpa