Regulatory Affairs Specialist
OrganOx
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.
Job description
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.
Major 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
- This role will require that you work at the Giralda office in Madison NJ for approximately 2 days per week, subject to your manager’s direction. This role will require some travel within the US and at times to the UK.
Qualifications
- 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
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
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Disability coverage
- Flexible spending accounts
- 401(k) retirement plan
- Paid time off
- Holidays
- Employee discounts
- Onsite wellness facility
Company overview
OrganOx is a pioneering medical technology company specializing in advanced organ preservation devices for transplantation. Founded in 2008 as a spin-off from the University of Oxford by Professor Peter Friend and Professor Constantin Coussios, the company developed the world's first normothermic liver perfusion device, the metra® system. This innovative technology enables normothermic machine perfusion (NMP), which preserves organs at near-body temperature by circulating oxygen and nutrient-rich perfusate, allowing for real-time monitoring of organ condition during storage and transport. The metra® system has been used in over 6,000 liver transplant procedures globally and has received regulatory approvals in the U.S., Europe, Australia, and Canada. OrganOx's technology addresses critical challenges in organ transplantation by improving organ utilization rates, enabling the use of marginal donor organs, enhancing post-transplant outcomes, and reducing the burden on healthcare professionals. In 2025, the company was acquired by Terumo Corporation for approximately $1.5 billion, marking Terumo's strategic entry into the organ transplantation sector. OrganOx continues to expand its technology platform, with investigational applications for kidney transplantation and partnerships for innovative organ support solutions.