Senior Regulatory Affairs Specialist

Senior Regulatory Affairs SpecialistOrganOx 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.The Senior Regulatory Affairs Specialist is responsible for leading and supporting regulatory activities for assigned devices and projects throughout the product lifecycle. This role develops regulatory strategies, performs regulatory assessments for product and process changes, and prepares submissions and other regulatory deliverables for the US and applicable international markets.This is a hybrid position in Madison, NJ, and may require up to 5% travel to OrganOx and/or supplier locations.Major ResponsibilitiesUnder direction from the Director, Regulatory Affairs, the Sr. Regulatory Affairs Specialist will be responsible for:Leading and supporting pre-/post-market regulatory activities for assigned devices, projects, and product changes.Performing regulatory impact assessments for design, labelling, packaging, supplier, and manufacturing changes to determine appropriate regulatory pathways and submission requirements.Preparing, compiling, and coordinating regulatory submissions and change notifications, including PMAs, PMA supplements, amendments, annual reports, and other change notifications or submissions.Supporting regulatory authority interactions by drafting correspondence, coordinating response strategies, tracking submission progress, and preparing responses to requests for additional information.Partnering with project teams to define regulatory requirements, review supporting documentation, and help ensure development and change activities are aligned with applicable regulatory expectations.Reviewing documentation and evidence that may support regulatory activities, including verification and validation documentation, risk management documentation, and change records.Contributing to departmental process improvements, regulatory intelligence activities, and internal tools or procedures that improve consistency, compliance, and efficiency.Providing training and support to other members of the department.Adhere to the letter and spirit of OrganOx's Code of Conduct and all other company policies.