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). It's 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 Intake Specialist is responsible for supporting the complaint intake obligations and management of communication between internal stake holders, field personnel and/or customers for all medical device complaint activities. This role will report directly to the Complaints and Vigilance Manager, North America. 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 exhaustive.
This is an onsite/remote position in Madison, NJ to ensure complaint reporting compliance.
Major Responsibilities
Under direction from the Complaints and Vigilance Manager, North America, the Intake Specialist will be responsible for:
- Initiating complaints and ensuring all required information is gathered and added to the complaints file in an accurate and timely manner.
- Monitor and lead the reporting inbox(es) for global complaint intake.
- Communicate with Customers, internal stakeholders, and field representatives in a professional manner to gather complaint information.
- Escalating adverse events per processes and/or procedures, when applicable.
- Supporting service and repair events including evaluation of intake information and review of repair activities to assess whether a complaint is warranted.
- Ensuring complaints are prioritized based on patient, product, and compliance risk.
- Facilitating complaint device returns investigations.
- In conjunction with internal team, Engineering and/or Clinical, completing complaint records/investigation reports using concise and grammatically correct English (appropriate for regulatory review).
- Assisting in reviewing and closing complaint files/records in a timely and accurate manner.
- Supporting of 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.
- Maintaining QA related logs and databases (e.g., Complaints, MDRs etc.)
- Other duties as assigned.
- This role may require travel up to 10% (including travel to the U.K.)
- Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies
Skills & Experience
- Ability to collect, organize and analyze 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 (i.e., Word, Excel, PowerPoint).
- Excellent verbal and technical writing skills.
- Ability to work independently
- Qualifications
- Minimum of 1-2 years related work experience is required.
- Bachelor’s degree in engineering, science or nursing or the 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 UK, EU, Canada and/or Australia
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.
