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Hire Divya G.

United States

NubGenix is a consulting organization who provide core solutions for your modern medical device and combination product

Profile Summary

NubGenix mainly focuses to support start up and mid-size medical device, combination products and pharmaceutical organizations. We provide support from early development through post-market phases. We also assist in designing, establishing and execution of complete Quality Management System (QMS).

Subject Matter Expertise

• ★ Medical Device Development
• ★ Quality Assurance & Quality Control (QA/QC)
• ☆ Healthcare Quality Improvement
• ☆ Product Development
• ☆ Medical Device Regulatory Writing
• ☆ Technical & Scientific Writing

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Technical Writing, Copywriting

Research Market Research, User Research, Meta-Research, Feasibility Study, Fact Checking, Gap Analysis, Gray Literature Search, Systematic Literature Review

Consulting Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis

Product Development Formulation, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Manufacturing, Concept Development, Prototyping

Work Experience

Founder and CEO

NubGenix Consulting LLC

August 2021 - Present

Associate Director, Quality

Takeda Pharmaceutical Company

December 2017 - July 2021

Plant Quality Manager

Becton Dickinson

April 2016 - December 2017

Quality manager

B Braun

September 2014 - March 2016

Education

Masters in Biomedical Engineering (Medical Device Commercialization Focus)

New Jersey Institute of Technology

August 2004 - May 2006

Instrumentation Technology

Viswesvariah Technology Institute

August 1999 - August 2003

Certifications

• Certified Manager of Quality/Organizational Excellence

  American Society for Quality

  August 2010 - January 2021