Navanit Pathak

About Navanit Pathak

Hi, I\'m Navneet Pathak, a Postgraduate in Medical Devices from NIPER-Ahmedabad. Currently, I work as a Senior Associate Medical/Clinical Writer in Regulatory Affairs at Freyr Solutions. My expertise spans medical device regulation (MDR), ISO 13485, quality management systems, clinical evaluation, biocompatibility testing, and technical file creation. with 6 years of experience.In my current role, I manage the preparation of clinical evaluation reports (CER) from scratch, including developing comprehensive literature search strategies using databases like PUBMED, M-library, Google Scholar, and Cochrane. I am adept at drafting various regulatory documents such as Clinical Evaluation Reports (CER), Scientific Validity Reports (SVR), and Clinical Performance Reports (CPR). Along with this i am handling product registration in Australia and New Zealand market.My academic experience includes biomaterial development and characterization, collagen isolation and purification, animal cell culture, SDS-PAGE, and manuscript writing. I am passionate about research and regulatory affairs, aiming to solve complex problems innovatively.With a strong foundation in technical knowledge and excellent communication skills, I am dedicated to continuously learning and exceeding expectations in the medical writing and clinical evaluation domain.

Experience

1. Senior Regulatory Specialist Clinical Medical Writer

   美敦力

   Aug 2025 — Present · Hyderabad, IN

   Clinical Evaluation Medical Writer

Education

• National Institute of Pharmaceutical Education and Research - Ahmedabad

  M.s pharm, Medical devices

  2017 — 2019

• Rajiv Gandhi Prodyogiki Vishwavidyalaya

  B.pharm, Pharmacy

  2013 — 2017