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Sona Bhardwaj

@sonabhardwaj

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I build FDA regulatory strategies and quality documentation for medical devices, clinical studies, and pharmaceuticals.

United States

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What I'm looking for

I'm looking to expand my regulatory affairs knowledge while supporting safe, impactful biomedical solutions through FDA strategy, quality systems, clinical regulatory documentation, and cross-functional collaboration.

I've developed FDA regulatory strategies for GE HealthCare and MedikEquip, evaluating AI/ML Software as a Medical Device, drafting Q-Sub questions, and building classification documentation for a motorized patient transfer device.

At MedikEquip, I classified PowerSlider as a 510(k)-exempt Class II medical device and prepared classification rationale, predicate research, registration materials, and design-control documentation aligned with 21 CFR 820, ISO 13485, and IEC 60601.

I've also supported clinical regulatory writing at Aroga Biosciences, amending a first-in-human oncology protocol, summarizing patient safety narratives, and compiling clinical regulatory documents. My pharmaceutical quality experience at Sun Pharmaceutical Industries includes analytical testing, GMP documentation, deviation and OOS investigations, CAPA support, and quality-record review.

I'm completing an MS in Biomedical Regulatory Affairs and continue building practical knowledge across FDA submissions, SaMD, clinical research, medical writing, and quality systems to help bring safe biomedical solutions forward.

Experience

Work history, roles, and key accomplishments

Regulatory Affairs Co-op

GE HealthCare

Nov 2025 - Jun 2026 (7 months)

Conducted systematic function characterization and analysis of LLM-based SaMD against US FDA AI/ML and SaMD guidance frameworks. Developed regulatory strategy documentation, including predicate device analysis and Breakthrough Device Designation eligibility, and drafted Pre-Submission (Q-Sub) questions.

Regulatory Strategy FDA Guidance Documents SaMD Predicate Analysis Breakthrough Device Designation Q Submission Documentation

Regulatory Affairs Intern

MedikEquip LLC

Jun 2025 - Dec 2025 (6 months)

Developed regulatory strategy for a novel motorized lateral patient transfer device, classifying it as 510(k)-exempt Class II under US FDA guidelines. Prepared design documentation, predicate device research, and registration materials in compliance with IEC 60601, 21 CFR 820, and ISO 13485.

510(K)Regulatory Strategy Predicates FDA Submissions IEC 60601 1 21 CFR 820 ISO 13485 Design Control

Regulatory Medical Writing Intern

Aroga Biosciences

Jun 2025 - Jul 2025 (1 month)

Amended protocols for a First-in-Human Phase 1 Oncology clinical study, ensuring compliance with GCP and ICH E6/E9. Summarized patient safety narratives for AEs/SAEs using CIOMS forms and compiled clinical regulatory documents including IBs, DSURs, and CSRs.

Medical Writing Protocols GCP ICH E6 ICH E9 CIOMS Safety Narratives ICH E3 Clinical Study Report Awareness Investigator Brochures DSURs CSR

Scientific Assistant

IISER / HBCSE-TIFR (Vigyan Pratibha)

Jul 2022 - Feb 2024 (1 year 7 months)

Designed, documented, and managed experimental protocols and learning units in a research environment. Organized and coordinated workshops and training sessions, developing communication and project coordination skills.

Experimental Design Documentation Project Coordination Workshop Organization

Research Trainee

RASA Life Science Informatics

Apr 2022 - Mar 2023 (11 months)

Conducted research on Monkeypox virus protein interactions with natural compounds using bioinformatics tools for molecular docking and simulation studies. Prepared structured research reports and documentation following scientific standards.

Bioinformatics Molecular Docking AutoDock Discovery Studio Research Documentation

Analytical Chemist

Sun Pharmaceutical Industries Limited

Feb 2019 - Feb 2022 (3 years)

Documented analytical testing of APIs and raw materials to prepare drug specifications and ensure GMP and ICH compliance. Prepared deviation and OOS investigation reports, supported CAPA activities, and reviewed batch history records and QC documentation.