Deepshikha Bhandari
SVP Quality, Regulatory and Clinical Compliance at Personalis, Inc.
- Role
- SVP Quality, Regulatory and Clinical Compliance at Personalis, Inc.
- Location
- Fremont, CA, US
- LinkedIn followers
- 500 followers
About Deepshikha Bhandari
Agile, multifaceted global leader with >20 year’s experience as a marketing and regulatory affairs professional in the medical device industry. Extensive experience with a broad spectrum of devices and therapies, including Digital Health, NGS and Companion Diagnostic IVD assays and Class Cardiovascular devices. Excellent understanding of global regulatory, clinical and quality requirements. Demonstrated success in building global regulatory teams and driving innovative strategies to secure global approvals in a VUCA (volatility, uncertainty, complexity, and ambiguity) environment.
Experience
SVP Quality, Regulatory and Clinical Compliance
Oct 2023 — Present · Fremont, CA, US
Provide strategic QRC leadership and direction towards Molecular Residual Disease (MRD) focused biopharma partnerships including companion diagnostics, facilitate Individualised Neoantigen Therapy development and enable Phase I, II and biopharma trials. Ensure compliance with FDA 21 CFR Part 820, FDA 21 CFR Part 812, New York State Department of Health (NYSDOH), California Department of Public Health (CDPH), ISO 13485:2016, CLIA, CAP and EU authorities.
Education
Jawaharlal Nehru Vishvavidyalaya
BA & MA, Japan Area Studies
お茶の水女子大学 / Ochanomizu University
MA, Ancient Japanese Literature
The George Washington University
Master of Business Administration (MBA), Health/Health Care Administration/Management
2010 — 2012
Skills
- Regulatory Submissions
- Clinical Development
- Design Control
- Regulatory Requirements
- Regulatory Affairs
- Lifesciences
- Gxp
- Iso 13485
- Clinical Trials
- Pharmaceutical Industry
- Sop
- Fda
- Oncology
- Medical Devices
- Clinical Research
- Capa
- Pharmaceutics
- Biotechnology
- Validation
- Gmp
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