SW test management, Regulatory affairs,project management

I have accumulated good experience & understanding of interacting and communicating with different internal/external units of product project management units R&D SW, HW, Marketing and regulatory bodies & authorities.

Main responsibilities are to make sure that the product complies with standards and requirements, Overview & definition of product life cycle and description of project phases.

Compilation of high quality official documentations for submission of authorization applications and archiving submission documentations in document management system for any future regulatory submission updates due to changes in internal organizational regulatory policies and procedures, requirements changes or external audits.

good experience & understanding of test methodologies, manual & automatic test planning, coordination, execution and verification. 

I am able to work as an independent and in team environments. Have a high self-motivation and flexibility to adapt to new situations.