Divya Sudha Bathina Venkatesh
Summary
Motivated Regulatory Affairs Professional with a background in Dentistry and a master's in Biomedical Regulatory Affairs. Experienced in regulatory documentation, compliance with FDA regulations, and ensuring adherence to GCP standards. Skilled in regulatory strategy development, managing regulatory submissions, risk analysis, and collaborating with cross-functional teams to support product development and approval in the medical device and pharmaceutical industries. Over four years of experience in patient management, demonstrating strong organizational and communication skills. Dedicated to ensuring regulatory compliance, accurate documentation, and seamless coordination with stakeholders to contribute to the success of regulatory processes and product lifecycle management. Passionate about advancing healthcare outcomes through effective regulatory strategies and compliance.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Registered Dental Assistant
Cosmetic and Family Dentistry
11.2022 - 01.2024
- Performed general chair-side duties for general dentistry, endo procedures, and oral surgery.
- Cleaned and sanitized dental tools and equipment, straightened treatment rooms, and restocked supplies.
- Documented patient dental health information, medical history, and vital signs for future reference.
- Sterilization of dental equipments to maintain infection control protocol.
Registered Dental Assistant
Fletcher Dental Care
10.2021 - 11.2022
- Successfully assisted dentist by performing four-handed dentistry and other chair-side duties.
- Sterilized trays, instruments, and disinfected surfaces for clean dental office setting and patient safety to adhere to infection control protocol.
- Updated patient records regularly after each appointment or procedure to ensure accurate documentation.
- Educated patients on dental hygiene, pre-surgical instructions and post-surgical care.
Dental Intern
Chettinad Dental College
09.2017 - 10.2018
- Developed proficiency in various dental procedures, such as teeth cleaning, extraction, and cavity filling, ensuring comprehensive care for patients.
- Supported patient education efforts by creating and distributing informative materials on oral health topics.
- Ensured accurate record-keeping by diligently updating patient charts with relevant information after each visit.
Study Assistant
Department of Orthodontics
10.2017 - 08.2018
- Coordinated with the Head of Department of Orthodontics (PI) for the study titled: Relationship between dental arch forms and dermatoglyphics. For this study, obtained Informed consent, oral impressions from 150 participants and fabricated subject oral models as the study protocol required. Assisted the PI with documentation requirements for IRB approval.
Education
Master of Science - Biomedical Regulatory Affairs
University Of Washington
Seattle, WA06-2025
Certificate - Clinical Research
University of Washington
Seattle, WA06-2023
Bachelor's - Dental Surgery
Chettinad Dental College & Research Institute
Tamil Nadu, India09-2018
Skills
- Knowledge of FDA Regulations
- Technical Writing
- Familiarity with International Regulatory Standards
- Risk Management ( ISO 14971)
- Quality Management Systems ( 21 CFR 820; ISO 13485)
- Knowledge of Regulatory Submissions including Pre-IND, Q-Sub Request, IND, NDA, BLA, 510(k), PMA, IDE
- Proficiency in Electronic Submissions Gateway (ESG) and Common Technical Document (eCTD) tools
- Proficient in tools like Microsoft Office Suite (Word, Excel, PowerPoint), & Adobe
- Detail-oriented, Adaptability, & Critical Thinking
- Team collaboration
- Continuous Learning
Certification
- GCP & ICH Certification CITI Program April, 2024
Timeline
Registered Dental Assistant
Cosmetic and Family Dentistry
11.2022 - 01.2024
Registered Dental Assistant
Fletcher Dental Care
10.2021 - 11.2022
Study Assistant
Department of Orthodontics
10.2017 - 08.2018
Dental Intern
Chettinad Dental College
09.2017 - 10.2018
Master of Science - Biomedical Regulatory Affairs
University Of Washington
Certificate - Clinical Research
University of Washington
Bachelor's - Dental Surgery
Chettinad Dental College & Research Institute
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