Ms. Rosenberg-Tzur works with CardioMed as an affiliate consultant, bringing over 20 years of experience in regulatory affairs and quality assurance in the medical device industry. She specializes in developing and executing regulatory strategies, guiding small and mid-sized medical device startups and companies through regulatory compliance and quality assurance challenges.
Experience
Her expertise includes pre-clinical verification and validation activities, ethylene oxide (EO) sterilization validation, as well as sterile barrier system validation. Additionally, she is skilled in quality system implementation, risk management, and biological safety.
She is highly experienced in compiling, writing, and assembling regulatory submissions, as well as drafting technical documentation to support global regulatory approvals.