Regulatory Affairs Specialist

OrganOx•Madison, NJ

2d•Hybrid

About The Position

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. 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.

Requirements

Working knowledge of FDA processes for medical device compliance
The ability to write clear regulatory strategies and submissions
A good understanding of GMP compliance requirements in Quality Control
Experience in cross-functional collaboration with Manufacturing, Quality, R&D, Clinical and Marketing departments
Computer proficiency in MS Office (i.e., Word, Excel, PowerPoint)
Excellent verbal and technical writing skills
Ability to work independently
A BS degree in an engineering, life science, or related area
At least 3 years’ regulatory submission experience for Class II/III medical devices

Responsibilities

Preparing regulatory submissions (IDE; IDE Supplements; PMA; PMA Supplements, etc.) for submission to the FDA and Health Canada
Interfacing with the FDA and Health Canada on assigned projects
Responding to FDA and Health Canada requests for additional information
Interacting with FDA, Health Canada and/or Notified Body during quality inspections. Responsible for responding to requests for special reports during inspections
Keeping abreast of changes to US and Canada regulatory requirements and International Standards related to OrganOx products and processes
Formally communicating regulatory initiatives or changes in the applicable medical device law with company personnel, customers, subcontractors, regulatory agency representatives, and third party organizations
Reviewing regulatory guidances for assigned projects to ensure compliance with regulations and determining whether regulatory submissions are required
Prepare visualizations and conclusions for presentation to upper management
Working with key stakeholders in relation to Regulatory and Quality topic