• Bachelors/Master’s degree in various discipline of science with 2-4 years experience
• Preparation and review of all the documentations related to ISO13485:2016,QMS, MDR2017, DCGI/CDSCO, ICMR and other regulatory bodies in India and other countries
• Responsible for interacting with various stakeholders to ensure delivery of all regulatory and quality documentation for purpose of application to CDSCO or internal/external reporting.
• Face the audits related to regulatory which includes internal and external audits.
• Build a team for QA and Regularity audits.

• Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment.
• Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.