Ritwika Roy Email & Phone Number

California, United States

Lexington, Ma

- Led the preparation of document packages for regulatory submissions and license renewals of Class II IVDs across multiple regions (Asia Pacific, the Middle East, EU countries), resulting in expedited approvals and a significant market share expansion. - Enhanced regulatory compliance for CE-marked devices by collaborating with Quality and Marketing to update product labeling, IFUs, promotional and advertising materials, aligning with EU regulations. - Revamped internal and external audit processes by refining SOPs, leading to overall increase in efficiency and contributing to ISO 13485 certification readiness.

Capstone Project

As part of NT’s mission to advance Boron Neutron Capture Therapy (BNCT), I contributed to a critical project focused on the remediation and optimization of the quality management system (QMS) for the nuBeam Treatment Delivery System (TDS). This project was essential to achieving compliance with ISO 13485 and Medical Device Single Audit Program (MDSAP) standards across three major jurisdictions: the United States, European Union, and Japan.• Conducted gap analyses to identify areas of non-compliance and implemented corrective actions based on audit findings to ensure readiness for Stage 2 certification audits.• Developed and implemented a robust remediation strategy to address internal and Stage 1 certification audit findings.• Updated standard operating procedures (SOPs), Quality forms, and design history file (DHF) to align with ISO 13485:2016, MDSAP requirements, and to support regulatory submissions in the US (FDA), EU (MDR), and Japan (PMDA).• Prepared CAPA and Non-conformity assessments with NC grades to receive feedback from NT and incorporate them into technical documents.• Ensured the integration of risk management principles across all processes, including design controls, post-market surveillance, and supplier quality management.• Prepared the organization for Stage 2 certification audits by implementing corrective actions and verifying their effectiveness.

Lexington, Ma

Bengaluru, Karnataka, India

• Actively collaborated with the Clinical Project Lead, Global Trial Manager, Clinical Research Associates (CRA), and Regulatory and Start-Up (RSU) team to streamline clinical tracking systems and study documentation for Phase I-IV Oncology studies to track site compliance and performance within project timelines.• Enhanced document management by implementing rigorous quality control procedures to thoroughly examine, classify, file, and archive essential clinical documents into the electronic Trial Master File (eTMF) and Veeva CDMS.• Spearheaded the creation of critical data-driven trial reports and dashboards to analyze CRA metrics, monitoring visit schedules, and proactively identifying areas of improvement, minimizing errors by 35% and enhancing trial outcomes.• Played an instrumental role in training and onboarding new staff members, developing comprehensive training materials and operational workflows for new databases such as Veeva CDMS and TrialForce.• Hands-on experience with Clinical Trial Management System (sCTMS), Oracle InForm (eCRF), Veeva Vault/eTMF, Veeva CDMS, Investigator Space, Shared Investigator Platform (SIP), TrialForce and Business Intelligence Tool such as Spotfire.

Bengaluru, Karnataka, India

• Played a pivotal role in Biocon's cell line development project, demonstrating expertise in preparing mammalian cell cultures through efficient utilization of polymeric filtration and centrifugation techniques, followed by column chromatography using an 80mm column with a 2000L PH flow rate. • Formulated and optimized fed-batch cultures, employing advanced instrumentation processes such as SDS Page, Western Blot, and HPTLC methodologies, ensuring accurate data collection and maintaining 100% GLP compliance across all analyses.• Strategized and executed laboratory analyses to generate data for further upstream processing, gaining hands-on experience with industry-scale Bioreactors, Laminar Airflow systems, Centrifuges, ViCELL XR Cell Viability Analyzer, YSI Biochemical Analyzer, and Automated Cell Counters.

Ms In Regulatory Affairs In Drugs, Biologics And Medical Devices, 3.89/4.0

Activities and Societies: Regulatory Affairs Professional Society (RAPS)Concentration - Medical Device Regulatory Affairs Related.

Bachelor Of Pharmacy - Bpharm, 3.7/4.0

High School, Cbse