Apoorva Agarwal

About Apoorva Agarwal

As a Regulatory professional for Volk Optical Inc, I am responsible for ensuring compliance with regulatory requirements for 150+ countries. I am a key regulatory resource for the design and development of Class 2(a)[EU]/ Class 2 [FDA] devices. I am the project leader for EU MDR Transition and UKCA Transition. I play a pertinent role in Global Field Safety Notification. I am a seasoned Clinical Evaluation and Risk Assessment person. Working with a multicultural team, I have developed excellent communication and leadership skills. My experience in strategy consulting has honed my problem-solving skills. I am committed to ensuring that Volk Optical Inc. remains compliant with all regulatory requirements while continuing to innovate and grow.Previous to the current profile, I had a small stint as Head Regulatory Affairs for GPC Medical Limited. I helped them with the ISO 13485:2016 Audit during my tenure there. Before that, I was associated with Datt Mediproducts Pvt. Ltd for 8 years. They promoted ‘Make in India’ by venturing in Advanced wound care Class Medical devices. During 20••••21, I was part of the Design and development team had significant contributions. My journey has led me to achieve manufacturing license from CDSCO for the Devices. Achieved ISO13485:2016 certification for class devices and CE certification. I had applied for USFDA 510(k) for one of the devices which was under substantiative review at the time I left. My initial days saw me indulged in biocompatibility studies (as per ISO 10993) and stability studies (ICH and ASTM 1980). Then I was part of various validations (Product and packaging both). During the class device project, I have learned and grown a lot including keeping myself updated with the latest regulations. I successfully completed internal auditor training on ISO 13485: 2016 (from TUV SUD) and 21 CFR Part 820 (from AAMI, VA, USA). I was involved in clinical evaluations based on MEDDEV 2.7.1 rev 4 and learned a lot during the process. My passion for research can be traced back to my first job as a junior research fellow with CSIR – IGIB (National laboratory). During that time I was associated with the prestigious AIIMS hospital in one of five largest birth cohort studies in the world.I’m hopeful and positive about my work and aim to make a mark in this versatile and growing Industry.Please reach over email at a••••••••@gmail.com if you have any interesting Medical Device topic to discuss or if I can be of any help to you in your submission struggles. Have a great day!

Experience

1. Director of Regulatory Affairs

   Volk Optical Inc.

   Aug 2025 — Present

Education

• Institute of Pharmacy, Bundelkhand University

  M Pharma, Pharmaceutics

  2010 — 2012

• Institute of Pharmacy, Bundelkhand University

  Bachelor of Pharmacy (B.Pharm.), Pharmacy

  2006 — 2010

• Annamalai University

  Post Graduate Diploma in Quality Assurance and International Regulatory Affairs, Drug Regulatory Affairs

  2011 — 2012

• Delhi Public School, Vidyut Nagar

  12th, Physics, Chemistry, Biology, Maths

  1991 — 2005

Skills

• Capa
• Biotechnology
• Compliance
• Pharmaceutical Industry
• Sop
• Sds-Page
• Corrective and Preventive Action (Capa)
• Glp
• Molecular Biology
• High-Performance Liquid Chromatography (Hplc)
• Gmp
• Technology Transfer
• Pharmaceutics
• Drug Discovery
• Hplc
• Life Sciences
• Quality Management
• Biopharmaceuticals
• Genomics
• Generic Programming
• Standard Operating Procedure (Sop)
• Risk Assessment
• Dna
• Clinical Trials
• Elisa
• Formulation
• Pharmacokinetics
• Genetics
• Microbiology
• Clinical Development
• Regulatory Affairs
• Lifesciences
• Uv
• Chromatography
• Anda
• Pcr
• Pharmaceutical Research
• Validation
• Biochemistry
• Good Laboratory Practice (Glp)