Bathija

Ensured full compliance with the Medical Device Regulation (MDR) standards for a Class I device, facilitating its registration in both the European and Saudi Arabian markets. Specifically, the project aimed at remediate the existing Design History File (DHF) to meet the updated regulatory requirements outlined in the MDR.

As a Student Ambassador for Northeastern University - CPS through The Ambassador Platform since September 2023, I have taken on a pivotal role in representing the university to prospective students. My responsibilities include engaging in meaningful conversations to answer questions, provide insights, and share my personal experiences, helping prospective students make informed decisions about their educational options. To date, I have had 35+ such conversations, consistently receiving excellent feedback for my ability to connect with and assist these students. Additionally, I have collaborated with the marketing department to create social media posts that highlight the strengths and opportunities available at Northeastern University - CPS, contributing to the university's public communications. This role has significantly enhanced my skill set, particularly in areas critical to professional success. Through direct interaction with prospective students, I have refined my interpersonal and communication skills, ensuring clarity and empathy in every conversation. My customer service abilities have been strengthened as I navigate various inquiries, often requiring thorough research and collaboration with staff and fellow Ambassadors to provide the best possible information. Moreover, creating content for social media has honed my marketing and creative skills, while balancing these responsibilities with my studies has improved my organizational and time management capabilities. This experience has not only prepared me for future challenges in my MS in Regulatory Affairs but has also deepened my commitment to supporting others in their educational journeys.

•Owned MDD to MDR (EU 2017/745) remediation documentation of Design History Files for 3 product families i.e., prepared regulatory documentation, labels for registration of devices in EU •Renewed the annual FDA establishment registration for the medical device manufacturer, Tecomet •Assisted and gained front room experience in the British Standards Institution (BSI) Audit ISO 13485:2016 •Prepared EU Declaration of Conformity (DoC) for multiple medical device families •Worked on Corrective & Preventive Action (CAPA) by remediating an Approved Supplier List (ASL) gap analysis •Declared the presence of SVHC elements and animal origin substances per ISO 22442-1 •Completed multiple client surveys and provided them with required Quality documentation and ISO 13485 certification •Contributed to averting patient harm in dental surgeries by investigating a device defect through comprehensive analysis for a field complaint •Provided technical documentation, validation, CER, biocompatibility report, IFU, DoC, ISO certification etc. for supporting registrations to gain access to new markets •Declared and signed Country of Origin (COO) document for multiple devices •Facilitated compliance with EU import Regulation 833/2014 with set timelines by providing raw material certifications, ensuring seamless customs clearance, critical for guaranteeing timely patient surgeries •Reviewed multiple engineering change requests (ECR/ECO) and Nonconformance Reports (NCR) •Created a Post Market Surveillance Report using the MAUDE data and complaints database (QMS software) •Initiated change control process for critical QMS (PMS) documents and collaborated with teams to review customer complaints, deviations, investigations, non-conformances and CAPA development •Provide quality assurance support to the MRB team to identify losses and determine corrective actions/lasting solutions related to raw materials, in-process materials and final products to promote continuous improvement

• Drove business development and new product development projects by expanding into 5 new markets through competitive analysis and comprehensive market research, boosting market penetration by 50% • Served as a liaison with the RA team, ensuring detailed and timely submission of all regulatory matters, managing and tracking drug registration, and re-registration processes for more than 100 drug products • Communicated with multiple internal and external stakeholders for ensuring compliance with drug dossier filing processes • Executed frontline coordination with the country manager of Myanmar and Vietnam for analyzing operational problems ensuring their timely resolution; provided back-end operational support to Myanmar, Thailand, Singapore, Malaysia, etc. • Led the cross-functional collaboration and coordination with the Russian & RA team for the creation of Dossiers. Spearheaded the projects on new product development, sales force effectiveness, etc. for Russia CIS

•Evaluated the effectiveness of the stockist performance to identify the top-performing stockists •Analyzed the performance and effectiveness of distributors in terms of the potential and growth, collected data, and conducted a trend analysis & recommended steps to increase the awareness of Vymada as an effective medication for heart patients in reducing the risk of Cardiac failure •Conducted comprehensive Retail Chemist Prescription Audit for 400 chemists, addressing its supply chain gaps •Conducted an IP Tracker Analysis to assess where the company stands in the marketplace as compared to competitors and to gain insights on opportunistic areas- Hospitals with high potential and low penetration

•Kshamta is the Social responsibility forum of SVKM’s NMIMS, Shobhaben Pratapbhai Patel school of Pharmacy and Technology Management, 2019-2020 •I Led a team of 90-100 students to conduct Free health camps, Food donation drives, and medical camps for the underprivileged

•Headed a team of 12 people •We arranged and got several sponsorships for our events from potential sources

•Reviewed Biosimilar and Protein therapeutics to ascertain proper formulation requirements •Observed and reviewed several instruments’ functionality such as PH meter, Dynamic Light Scattering, Chromatography etc. in the formulation development lab

•Involved in Business Development and Marketing team for the product ‘Soapen’, visited and approached potential client stores to ensure availability of the product at various platforms

Coursework: Regulatory Compliance and Practice, FDA and Pharmaceutical Regulation, Regulatory Strategy and Product Development