Senior Regulatory Affairs Specialist - Software
ABOUT ORGANOX:
OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 7,000 liver transplant operations globally. OrganOx was also recently acquired by Terumo corporation (TSE:4543). Founded in 1921, Terumo Corporation strives to fulfill its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.
Position Summary
The position of Senior Regulatory Affairs Specialist is responsible for preparing regulatory submissions (e.g. Q-Submissions, INDs, IDEs and PMAs) for North America as well as assisting in the implementation of the company’s quality goals and objectives.
Other responsibilities include assisting with compliance activities related to ISO, GMP and applicable medical device standards.
This role will report directly to the Director, Regulatory Affairs, Software and Innovation and
