Regulatory Affairs Specialist

Regulatory Affairs Specialist

OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). Its flagship platform, the metra, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) 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 Regulatory Affairs Specialist is responsible for preparing regulatory submissions (IDEs and PMAs) for North America as well as assisting in the implementation of the company's quality goals and objectives. This position will be remote.

Other responsibilities include assisting with compliance activities related to GMP and ISO regulations and associated standards, as well as, assist in the performance of internal quality and regulatory compliance audits.

This role will report directly to the VP of Regulatory Affairs and Quality, North America and will also work closely with the Regulatory Affairs Manager located in the UK.

Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally inclusive, and the person will be expected to complete tasks reasonably requested by the VP of Regulatory Affairs and Quality, North America.