Saurav Nair

About Saurav Nair

Graduated as a Regulatory Affairs Professional from Northeastern University, which helped me to gain academic knowledge in various advanced nuanced topics such as Medical device/ Drug regulations as per US FDA & EU, Quality system management as per FDA & ISO, Overall Regulatory project management & strategy, SAMD Regulation & Quality Assurance, I have also gained knowledge on advanced skills such as writing NDA, PMA, ANDA,510K and their timelines. My Undergraduate major was Pharmacy from University of Mumbai where I learnt in depth about Biotechnology & Drug development, Device development, Pharmaceutical Engineering, Pharmaceutical Analysis, Pharmacology, Industrial Pharmacy.My professional experience in Quality Assurance in Device Design Quality & Clinical Trial Quality taught & gave me skills in ISO, ICH, IRB protocols, FDA standards, writing SOPs, Design & Process Controls, Validation protocols, Verification methods, Quality tools such as Fishbone, 5 whys, CAPAs, Change control, as well as Risk management tools like Hazard matrix, FMEA etc.I am Keen and Interested to learn and expand my knowledge in Medical Device, Pharmaceutical & Clinical trial Regulation and Regulatory Affairs.

Experience

1. Quality Assurance Specialist Ii

   AbbVie

   Feb 2026 — Present · Worcester, MA, US

   Working on QA for Biologics, and working on various aspects of Quality from Supplier, In Process & Post Market Quality

Education

• Mithibai College of Arts Chauhan Institute of Science and A.J. College of Commerce and Economics

  H.S.c, Science

  2012 — 2015

• Northeastern University

  Master of Science - MS, Regulatory affairs

• University of Mumbai

  Bachelor of Pharmacy - BPharm, Pharmacy