
ABOUT US

Bella Mitsel
Senior RA & QA Consultant
Bella has 13 years of experience in management of Quality Assurance
and Regulatory Affairs in the Medical Device industry.
Bella has expertise in creation, implementation and maintenance of the Quality System and Quality Processes in compliance with FDA 21 CFR Part 820 Quality System Regulation. In addition to compilation of EU Technical Files and management and execution of key validation processes for sterile products such as sterilization, shelf life, and transportation.
Prior to BioVision, Bella was a medical device QA&RA Project Manager and Team Leader at GSAP- a Medical Device consulting company. She was responsible for training and qualification of employees, monitoring of projects progress and providing professional support and communication with customers.
Prior to joining GSAP, Bella served as the QA Manager/ QA Engineer at EQUASHIELD Medical Ltd. She was responsible for QA, V&V activities and maintenance of Regulatory Affairs.
Bella served previously as the QA Engineer at Medimop (West), and as an Analytical Laboratory Team Leader at Mediline a Pharmaceutical Company.
Bella holds a BSc. in Biotechnology Engineering, and an ME in Industrial Engineering & Management, Quality Assurance and Reliability, both from the Technion Institute.
