Reshma R. Email & Phone Number

Chicago, Us

• Developed and executed clinical strategy for global trials of new AI products for obstetric indications, ensuring compliance with FDA guidelines and GCP requirements.• Led clinical activities to achieve project milestones, oversee project progress, and maintain relationships with investigational sites and KOLs.• Generated final reports to support regulatory filings and managed budget allocation for clinical strategy development.

Beverly, Massachusetts, Us

• Development of clinical study strategies and protocols to support the validation of new medical and in vitro diagnostic devices, • Prepare and present clinical study strategies and protocols for regulatory bodies including the US FDA, • Creation of Clinical and Analytical Study Protocols and supporting plans and procedures, including Informed Consent Forms (ICFs), • Monitoring Plans and Data Collection Forms in conjunction with the assigned Project Team, • Assist clients in identifying and contracting with potential Clinical Trial Sites and/or Reference Laboratories, • Assist with Institutional Review Board (IRB) submissions, • Lead and Manage internal and external resources to support all aspects of clinical and method comparison studies in accordance with Good Clinical Practice, • Monitor and analyze clinical study data and report on performance both internally and with study sponsors, • Prepare study reports to support Regulatory Filings such as FDA 510(k), de novo and PMA submissions, Health Canada Licensure, EU Technical Files, etc, • Provide input on content of submission documents based on experience, regulations and guidance available from regulatory bodies, • Implementation of regulatory and clinical processes as they relate to company procedures, clinical studies, testing, and documentation and ensure that they are communicated through company policies and procedures

Piscataway, Nj, Us

Pa Pennsylvania, Pa, Us

Product Life cycle management, monitor and evaluate research and development/ innovation of products, supervisor for biochemical and molecular based test devices, managing multiple projects, budget allocation, Clinical research, principal investigator, institution review board (IRB,) external client communications, medical device clinical studies, clinical and non-clinical testing, FDA regulatory protocol writing, market analysis, Project management, schedule management, line manager, implementing, designing, and administering clinical, quality, regulatory, or commercial applications, client and investor liaison, 510k submission, mentor team members, HIPAA grant writing, statistical analysis.

Pa Pennsylvania, Pa, Us

Research and Development Supervisor, Managing multiple projects, Principal Investigator, Institution Review Board, External Client communications, Medical device clinical studies, FDA Regulatory protocol writing, POC Device development, IVD Key performance indicator specialist, Molecular Diagnostics, Clinical and Non-clinical testing, product development, Class III Device development, Paper Microfluidics development, Quality check, Biomedical analysis, HIPAA certified

Pa Pennsylvania, Pa, Us

Research and Development, POC Device development, IVD Key performance indicator, Molecular Diagnostics, Clinical and Non-clinical testing, product development, Class III Device development, Paper Microfluidics, Quality check, Biomedical analysis, big data analysis

Philadelphia, Pennsylvania, Us

Department of Electrical and Computer EngineeringProject: Diagnostic and Pre-screening imaging device development for Breast tumor Job Responsibilities: Research and Development, Health device instrumentation, Grant writing, Graduate and Undergraduate research project supervisor, scientific publication writing, Clinical and Non-clinical testing, product development, Medical device Class I and Class II development, Quality check, Biomedical analysis, HIPAA &FDA regulation analysis, Biomechanical testing, project management

Princeton, New Jersey, Us

Reviews manuscripts in Journal of Nanoparticle Research- A Springer journal

Piscataway, Nj, Us

IEEE Sensors Journal Reviews manuscripts for its scientific credibility, and novelty.

Vellore, Tamil Nadu, In

Job Responsibilities: Research and Development, Health device instrumentation, Laser based studies, Grant writing, Pharmaceutical and natural product drug testing, Histopathological analysis, Urology and Kidney stone-based disease testing, treatment planning, screening device development, clinical research, Biomechanical orthopedic, cadaver testing, image processing, phantom preparation, blood and urine analysis, animal studies (mice), software installation

Thiruvananthapuram, Kerala, In

Job Responsibilities: Laser lithotripsy surgical assistance, sample collection, patient case study, kidney stone analysis, patient diet analysis

Vellore, Tamilnadu, In

Job Responsibilities: Biomechanical study, Clinical data analysis, Cadaver preprocessing, Statistical analysis, Device testing

Teaneck, New Jersey, Us

Job Responsibility: IT Programmer, Technical analyst, Hardware and software support analyst, customer and client service

Postdoctoral Fellowship

Doctor Of Philosophy (Phd), Biophysics

Master'S Degree, Electronics

Bachelor'S Degree, Electronics