Open to opportunities

Sona Bhardwaj

@sonabhardwaj1

Regulatory affairs professional at GE HealthCare who evaluated an AI-based SaMD pathway and prepared FDA Q-Sub questions.

United States

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What I'm looking for

I'm motivated to keep expanding my regulatory knowledge to support safe, impactful biomedical solutions that make a difference.

At GEHealthCare, I analyzed an LLM-based Software as a Medical Device against US FDA AI/ML and SaMD guidance to assess its regulatory pathway and classification. I also prepared strategy documentation and drafted questions for FDA feedback.

At MedikEquip LLC, I developed the regulatory strategy for PowerSlider, classifying it as a 510(k)-exempt Class II medical device. I prepared design and classification documentation aligned with FDA requirements and applicable quality standards.

At Aroga Biosciences, I amended protocols for a First-in-Human Phase 1 oncology study and prepared patient safety narratives for adverse events. I also reviewed and compiled clinical regulatory documents.

At Sun Pharmaceutical Industries Limited, I documented analytical testing of APIs and raw materials and supported GMP and ICH compliance. I prepared deviation and OOS investigation reports, supported CAPA activities, and maintained analytical data using LIMS and Empower.

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 Software as a Medical Device (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 Submissions SaMD AI ML Predicates Q Submission Breakthrough Device Designation 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 a 510(k)-exempt Class II medical device under US FDA guidelines. Prepared design documentation, predicate device research, and ensured compliance with 21 CFR 820 and ISO 13485.

Regulatory Strategy 510(K)FDA Submissions Predicates 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 standards. Summarized patient safety narratives for adverse events and compiled clinical regulatory documents including IBs, DSURs, and CSRs.

Medical Writing Protocols GCP ICH E6 ICH E9 Safety Narratives CIOMS ICH E3 Clinical Study Report Awareness 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, maintaining detailed records and ensuring accuracy. Organized and coordinated workshops and training sessions, developing communication and project coordination skills.

Research Documentation Protocol Design Project Coordination Workshop Organization

Research Trainee

RASA Life Science Informatics

Apr 2022 - Mar 2023 (11 months)

Conducted comprehensive 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 compliance with GMP and ICH requirements. Prepared deviation and OOS investigation reports, supported CAPA activities, and reviewed batch history records and QC documentation.