Vijay Mate

Experience

• 

  TechNova Imaging Systems (P) Ltd.

  Jan 1997 - Jan 2000

  • QA

    Jan 1997 - Jan 2000

  • QA

    Jan 1997 - Jan 2000
• 

  EMICOS International

  Feb 1999 - Apr 2004

  Executive- manufacturing
• 

  SGS

  Jan 2007 - Jan 2010

  Medical devices auditor

  Medical devices auditor

• 

  SGS Industrial

  May 2007 - May 2010

  Auditor -MEDICAL DEVICES/ISO 13485/QMS/EMS/GMP Second party Audits
• 

  Kiran Medical Systems Limited

  Jan 2009 - Jun 2013

  Manager QA and RA

  Quality assurance and Regulatory affairs

• 

  Tata Elxsi

  Jun 2013 - Sept 2017

  QA and RA MEBU

  Medical Electronics Business UnitQMS and Regulatory aspects of Design and Development Hardware & software for Medical Devices.. Actively involved in business development-presales activities.

• 

  Arjo

  Oct 2017 - Sept 2019

  Senior Manager Quality, Regulatory and Compliance
• 

  Philips

  Oct 2019 - Oct 2023

  Regulatory Affairs Specialist
• 

  Aegis Lifesciences Pvt Ltd

  Oct 2023 - now

  Head-RA and QA

  • Lead global regulatory strategy development, planning, and implementation for current and new Product introductions• Have the joint responsibility to develop, facilitate and execute comprehensive regulatory strategies through all phases of development and product life cycle, to accelerate and ensure successful product registrations and provides regulatory assessment and supports Change Control Assessment• Oversee maintenance of product quality and compliance through the Quality Assurance functions as well as management of the Quality Management System and compliance processes• Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects• Keep abreast of International legislation and guidelines of current product line in India• Compliance with respect to internal/external audits meeting regulatory/ accreditation requirements• Reviewing current accreditation/regulatory requirement, performing gap analysis and ensuring compliance to current requirements• Provide product specific Regulatory strategies to mitigate risk; works in conjunction with production, RA & QA team to provide advice on process and labeling changes• Review of SOPs, BPRs, specifications and change control to ensure compliance• Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks• Drives resolution of issues, communicates issues, impact and outcomes to the management team• Responsible for ensuring compliance to the submission standards, procedures and policies in India• Support Commercial Department in business development such as product evaluation and pre-launch activities Show less