Asok Kumar Raghavan Nair

About Asok Kumar Raghavan Nair

A strategic Medical device Quality Assurance and Regulatory Affairs professional with four decades of industry experience in Medical Device and Pharmaceutical industry. Involved in Medical device regulation formulation in India. Experience in Research & Development, Production, Quality Assurance & Regulatory Affairs in Medical devices; Strategic Planning & Project excecution. Member of many National and International committees(ISO,GHWP, IEC & BIS). Experience of 17 years in American MNC9Abbott, Johnson & Johnson and Covidien) as QA & RA Leader and 23 years in Indian Medical device and Pharmaceutical Manufacturing as QA and RA leader.Corporate QA Head and Management Representative of a multi location Govt of India company having Medical Devices, Pharmaceuticals and Vaccines in the product port folio. Co-ordinator and responsible for the implementation of the strategic plan of a comapany to take the company from Rs 200 Crores to crores. Was responsible for Regulatory affairs and PMS of Indian subcontinent in Covidien India Ltd and subsequently became the Director of Quality Assurance for Asia in Covidien Pte Ltd Singapore.Was the Vice President QA & RA Johnson & Johnson Medical India Limited( India,Sri Lanka,Bangladesh,Nepal) and now as Director Strategic Regulatory Affairs for India and SEA at Abbott- responsible for Regulatory Policy advocacy.Chair of Regulatory subgroup of CII Medical Technology forum, Chair Regulatory subgroup of Advamed India, Core group leader for Regulatory in Assocham and member of the Core group in Regulatory Subgroup for FICCI and an active member in the Regulatory Group of APACMed in South East Asia Region.Skills: Medical Device Quality Assurance and Regulatory Affairs, Quality Management System,Environmental Management System,Strategic Planning and quality auditing, Project excecution, Production of Medical devices,R&D of Medical devices, Capacity Building, and Medical Device regulation development Lead Assessor for ISO ISO and ISO 13485 with hand on experience in Medical devcie quality management system auditing as well as GMP auditing of Pharmaceutical manufacturing.

Experience

1. Director (Ra & Qa)

   Stryker (India) Private Ltd

   Aug 2025 — Present

Education

• TuV SuD

  Lead Asessor, Quality Management System ISO 13485

• Annamalai University

  Bachelors Degree, Chemical Engineering

  1980 — 1984

• Carmel Higher Secondary School

  HSC, Science stream

  1978 — 1980

• BvQI

  Lead Assessor, Environmental Management System ISO 14000

• BVQI

  Lead Assessor, Quality Management System ISO 9000

• SLB school

  SSLC, General

  1972 — 1978