Quality Assurance Manager

Company Description

Regentis Biomaterials Ltd ("Regentis") is a regenerative medicine company dedicated to developing innovative tissue repair solutions that restore the health and enhance quality of life of patients.

Regentis’ lead product is GelrinC, a cell-free, off-the-shelf hydrogel that is cured into a resorbable implant in the knee for the treatment of painful injuries to articular knee cartilage. There is currently no approved off-the-shelf product marketed in the United States for cartilage repair. GelrinC is already approved as a device with a CE mark in Europe, and Regentis is currently conducting a pivotal trial, under the FDA sanctioned protocol, in the United States and Europe.

Role Description

The Quality Management Manager will be responsible for overseeing all quality Management activities for Regentis Biomaterials. This is a full-time hybrid role, located in Herzliya with flexibility for mostly remote work. The Quality Management Manager will work closely with cross-functional teams to ensure compliance with applicable regulations and standards, including ISO 13485 and FDA requirements. Day-to-day tasks include developing and maintaining quality management systems, performing audits, managing documentation, leading investigations, and ensuring all products meet quality specifications.

Qualifications

·      At least 5 years experience in a QA/RA position in the medical device industry, including ISO 13485 and FDA QSR

·      Bachelor’s degree in engineering, chemistry or life science

·      Experience in regulatory activities in US and Europe

·      Experience in NB audits

·      Experience in manufacturing processes in clean rooms

·      Experience with combination Products an advantage

·      Experience with Aseptic Processes an advantage

·      Attention to detail and ability to work independently

·      Fluent English