Sangeetha Yedlapalli
Grayslake,IL
Summary
Experienced Regulatory Affairs Specialist with a robust background in biomedical equipment technology and instrumentation control. Currently skilled in managing regulatory submissions, ensuring compliance with industry standards, and developing regulatory strategies. Previously gained hands-on experience as a Biomedical Equipment Technician Intern, where I supported the maintenance and troubleshooting of medical devices, and as an Instrumentation and Control Engineer Intern, where I optimized control systems in industrial settings. Proven ability to bridge technical expertise with regulatory requirements to facilitate product approvals and enhance operational efficiency.
Overview
5
5
years of professional experience
Work History
Reglatory Affairs Specialist
Baxter International Inc
02.2024 - Current
- Responsible for preparing international submissions and FDA submissions include device 510(k), PMAs and assessing the impact of changes in regulations on product development and registration strategies.
- Reviewed and approved change requests to ensure they met regulatory requirements and company standards, including the FDA, EU MDR, and ISO 13485
- Coordinated and oversee the planning, and management of regulatory documentation activities.
- Performed documentation control processes to ensure accurate and up-to-date records and compliance with regulatory requirements.
- Performed submission activities for regulatory approvals including premarket approvals (PMAs), premarket notifications (510(k)s), and post-approval reports, establishment registrations, and listings.
- Prepared and submitted necessary documentation related to TCUs for regulatory approval.
- Evaluated and track audit response Corrective Action/Preventive Action (CAPA).
- Implemented a systematic approach to track the status and renewal dates of FSCs to prevent lapses in compliance.
- Managed the preparation and issuance of Certificates to Foreign governments (CFG) to ensure compliance with regulatory requirements for exporting products to specific countries.
- Assisted in updating Bill of Materials (BOM) with the new materials for Design Changes
- Performed in navigating the entire product life cycle, from preclinical development to post-market surveillance, ensuring compliance with regulatory agencies such as FDA.
- Utilized data analysis techniques to evaluate regulatory compliance and identify trends or areas for improvement.
Biomedical Equipment Technician Intern
Mamata Academy Of Medical Sciences
05.2023 - 08.2023
- Assessed and resolved biomedical equipment issues by executing precise repairs and performing preventive maintenance.
- Conducted thorough safety and environmental inspections to support healthcare delivery and adhere to regulatory compliance standards.
- Complied with company policies and hospital protocols, ensuring meticulous documentation of all maintenance and repair activities.
- Fostered robust customer relationships through proactive communication, ensuring effective issue resolution and sustained customer satisfaction.
- Maintained and calibrated tools and test equipment to deliver timely and accurate repairs and maintenance services.
- Promptly identified and escalated quality or compliance concerns to the Quality Organization, upholding the highest ethical standards in service provision
- Assisted in the calibration and testing of infusion pumps and ventilators to ensure precise operation and patient safety.
- Contributed to the development of preventive maintenance schedules, improving equipment reliability and longevity.
- Provided technical support and user training to healthcare professionals, enhancing their ability to operate and troubleshoot medical equipment effectively
Instrumentation and Control Engineer Intern
ITC PaperBoards & Specialty Papers
04.2019 - 07.2019
- Assisted in the calibration and maintenance of instrumentation systems used in paper production processes, ensuring accuracy and efficiency.
- Supported the implementation and monitoring of control systems for automated manufacturing operations, improving process stability and performance.
- Conducted data analysis and troubleshooting for instrumentation and control systems, identifying and resolving issues to minimize downtime.
- Collaborated with senior engineers to optimize control strategies, enhancing the quality and consistency of paper board products.
- Participated in the design and testing of new instrumentation and control solutions to meet project specifications and improve operational efficiency.
- Documented maintenance activities and system performance, contributing to detailed reports and compliance with industry standards.
- Provided technical support during system upgrades and installations, ensuring seamless integration with existing equipment and processes.
- Assisted in developing and implementing preventive maintenance schedules, reducing equipment failures and extending system lifespan.
- Gained experience with various industrial control systems, including PLCs, SCADA, and DCS, enhancing practical knowledge of automation technologies
Education
Master of Science - Biomedical Engineering
Florida Institute of Technology-Melbourne
Melbourne, FL12.2023
Bachelor of Science - Electronics And Instrumentation Engineering
VNR VJIET
Hyderabad,India08.2021
Associate of Science - Electronics And Instrumentation Engineering
Government Polytechnic College
Kothagudem, India05.2018
Skills
- Biomedical Equipment Troubleshooting
- Preventive Maintenance
- Regulatory Compliance
- CAPA Management
- Medical Device Regulation (MDR)
- Regulatory Audits
- FDA Regulations
- Regulatory Submissions
- Safety and Environmental Inspections
- Customer Relationship Management
- Tool and Equipment Calibration
- Quality and Compliance Reporting
- Technical Documentation
- Problem-Solving
- Communication
Languages
Telugu
Native or Bilingual
Hindi
Full Professional
English
Full Professional
Timeline
Reglatory Affairs Specialist
Baxter International Inc
02.2024 - Current
Biomedical Equipment Technician Intern
Mamata Academy Of Medical Sciences
05.2023 - 08.2023
Instrumentation and Control Engineer Intern
ITC PaperBoards & Specialty Papers
04.2019 - 07.2019
Master of Science - Biomedical Engineering
Florida Institute of Technology-Melbourne
Bachelor of Science - Electronics And Instrumentation Engineering
VNR VJIET
Associate of Science - Electronics And Instrumentation Engineering
Government Polytechnic College
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