I am having a total experience of 11 years which includes 3 years in medical industry as QA and Regulatory Lead.
Currently designated as Regulatory Lead for a start up in medical device industry, I am involved in processing the CE marking of the products designed and developed by the organization. I have successfully implemented ISO 13485 and played a key role in acquiring ISO 13485 for the organization. I am a certified Lead Auditor for ISO 13485 from BSI. Conducted several internal audits, introduced processes with respect to ISO 13485 requirements and successfully faced external audits.