Inhalation Sciences (ISAB) has appointed Helen Bäckroos as its Quality and Regulatory Affairs Manager. Ms Bäckroos, currently a Senior Consultant at Scandinavian Regulatory Services AB, takes up her post on February 15[th], 2021. The new role is crucial to ISAB's ongoing expansion as PreciseInhale[®] begins trials for clinical validation in Q1 2021 and global product sales continue to grow.
Helen Bäckroos takes position as ISAB's Quality and Regulatory Affairs Manager on February 15[th], 2021. As a Senior Consultant in a well-established, highly-skilled Swedish life-sciences consultancy, Bäckroos has extensive experience in Product Development and Quality and Regulatory Affairs for a wide range of medical devices. She has helped companies build quality systems and compliance from first ISO 13485 certification through to class III EC certifications.
ISAB CEO Manoush Masarrat: "We're pleased to welcome Helen to the team! In our strategic plan for 2021 we identified strengthening our regulatory competence as a key priority. As already communicated, a first clinical trial for the use of PreciseInhale[®]in humans is scheduled to start in Q1 2021, with results to be reported in Q4. Success in this will open up major new commercial opportunities for us and having excellent Quality and Regulatory Affairs skills inhouse will contribute enormously to ensuring that success."
Helen Bäckroos: "My number one goal is to contribute to the success of the company I am working for, ISAB are currently in the position where Regulatory and Quality management are key to growth, I'm pleased to be able to contribute to this exciting company at such an exciting moment for them."