Intake Specialist

About OrganOx 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 utilised 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 fulfil 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 Intake Specialist is responsible for supporting the complaint intake obligations and managing communication between internal stakeholders, field personnel and customers for all medical device complaint activities. This role will report directly to the Complaints and Vigilance Manager, North America. The position is onsite/remote in Madison, NJ and ensures complaint reporting compliance. Major Responsibilities Initiate complaints and ensure all required information is gathered and added to the complaint file accurately and in a timely manner. Monitor and lead the reporting inboxes for global complaint intake. Communicate with customers, internal stakeholders and field representatives in a professional manner to gather complaint information. Escalate adverse events per processes and/or procedures when applicable. Support service and repair events, including evaluation of intake information and review of repair activities to assess whether a complaint is warranted. Prioritise complaints based on patient, product and compliance risk. Facilitate complaint device return investigations. In conjunction with the internal team, engineering and/or clinical, complete complaint records and investigation reports using concise and grammatically correct English appropriate for regulatory review. Assist in reviewing and closing complaint files and records in a timely and accurate manner. Support ad‑hoc complaint metrics and data requests from key stakeholders such as regulatory, clinical, R&D, quality and manufacturing. Ensure associated communications are appropriately disseminated and documented as per the complaint file and/or additional requests. Maintain QA related logs and databases (e.g. Complaints, MDRs etc.). Perform other duties as assigned. Travel up to 10%, including to the U.K., may be required. Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies. Skills & Experience Ability to collect, organise and analyse information to identify product and quality problems. Working knowledge of material, process and product specifications and/or inspection techniques. Experience in cross‑functional collaboration with quality, manufacturing, supply chain, R&D and servicing departments. Computer proficiency in MS Office (Word, Excel, PowerPoint). Excellent verbal and technical writing skills. Ability to work independently. Qualifications Minimum of 1‑2 years of related work experience. Bachelor’s degree in engineering, science, nursing or equivalent work experience. Working knowledge of FDA processes for medical device compliance (e.g., 21 CFR 803 and 820). Additional qualifications that are not required but preferred: Experience with either Master Control and/or Trackwise. Working knowledge of organ perfusion medical terms. Knowledge of adverse event/vigilance reporting to the U.K., EU, Canada and/or Australia. Benefits We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage and flexible spending accounts. Additionally, we offer a 401(k) retirement plan with company matching after 90 days, paid time off, holidays and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work‑life balance and provides opportunities for ongoing professional development. #J-18808-Ljbffr