Bansal

💡 Highlights & Achievements: Spearheaded global regulatory strategies for implantable and absorbable surgical devices, securing successful product approvals in the EMEA region. Streamlined the renewal registration prioritization process, helping the organization save time and resources by focusing on high-revenue markets. Partnered cross-functionally with R&D, Quality, and Global RA teams to align site-level procedures with new global processes under the Inspire Quality Project, improving compliance and operational efficiency. Strengthened regulatory intelligence monitoring, enabling early identification of changes in global medical device regulations and proactive alignment with evolving requirements. Supported change notifications to BSI and other authorities, ensuring uninterrupted market access and adherence to EU MDR expectations. Enhanced data accuracy by verifying attributes for upload to Product Information Management Systems (PIMS), driving consistency across global submissions. Contributed to a culture of quality and compliance by updating SOPs, supporting audits, and maintaining a high level of inspection readiness across the organization.

💡 Highlights & Achievements: Conducted comprehensive research on global submission requirements across regions including Europe, the Middle East, and Southeast Asia, supporting pre-market strategy for infusion pump systems. Contributed to the successful integration of cybersecurity measures into the product development lifecycle by collaborating with cross-functional design and engineering teams. Performed Regulatory Affairs Change Management Assessments (RACMA) to ensure compliance with global standards and identify potential regulatory risks early in the process. Delivered actionable insights on international regulatory trends, helping streamline global submissions and improve product readiness for diverse markets. Strengthened collaboration between Regulatory, R&D, and Quality teams, promoting a proactive approach to regulatory planning and documentation.

💡 Highlights & Achievements: Developed a comprehensive cybersecurity labeling template aligned with FDA premarket requirements, enabling medical device manufacturers to streamline documentation and reduce submission preparation time. Created regulatory submission templates for cybersecurity content across 510(k), PMA, and IDE pathways, tailored for both Class II and Class III devices. Reviewed and refined cybersecurity documentation to ensure completeness and compliance for pre-market submissions to global regulatory agencies. Led the design and implementation of the FDA Software Bill of Materials (SBOM) template, ensuring manufacturers met evolving cybersecurity submission requirements. Monitored global regulatory intelligence to stay current on emerging cybersecurity standards and supported teams in aligning documentation with the latest regulatory expectations.

• Analyzed the Semiconductor CHIPS legislation act in the U.S. based on budget allocation for NVIDIA to collaborate with the government to secure funding for advanced research on Artificial Intelligence. • Wrote a consolidated report describing an action plan to secure workforce development funding.

• Conducted continuous medical education programs among Health Care Professionals (hematologists, nurses) for factor VIII for Hemophilia treatment by collaborating with cross-functional teams. • Developed strategies and robust plans to secure government reimbursements to ensure product availability to patients. • Utilized skills in primary research initiatives, such as advisory boards, and meeting with stakeholders, to support the marketing and communication team on various projects related to interactive scientific posters as well as medical education. • Efficiently managed to deliver sales targets within stipulated timelines demonstrating effective project management skills.

• Interacted with cross-functional teams and assisted with the maintenance of online records for change control documentation. • Maintained compliance with regulations and Company policies and performed routine interactions with QA floor employees to ensure smooth operations. • Adhered to Standard operating procedures and also ensured Quality System is regularly updated to improve efficiency. • Assisted in performing root cause analysis for issues arising at the manufacturing facility and then incorporating CAPAs. • Reviewed quality documentation and ensured all records were up to date.

Relevant Coursework: Regulatory Compliance and practice, Regulatory strategy for Product Development and lifecycle management, Introduction to FDA Medical Device Regulation, Introduction to safety sciences, Human Experimentation Methodologies

Relevant Coursework: Pharmaceutical Jurisprudence, Pharmaceutical Analysis, Quality Assurance,Medicinal Chemistry, Pharmacology, and Quality Control