Senior Regulatory Affairs Specialist - Software

OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes worldwide. The company's first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has supported more than 7,000 liver transplant operations globally. OrganOx was recently acquired by Terumo Corporation (TSE:4543), a company founded in 1921 that strives to fulfill its mission of "Contributing to Society through Healthcare" by providing comprehensive healthcare solutions in over 160 countries and regions.

About the role

The Senior Regulatory Affairs Specialist is responsible for preparing regulatory submissions (e.g., Q-Submissions, INDs, IDEs, and PMAs) for North America and assisting in the implementation of the company's quality goals and objectives. This role supports compliance activities related to ISO, GMP, and applicable medical device standards, reporting directly to the Director, Regulatory Affairs, Software and Innovation. The position is flexible—remote or hybrid on-site in Madison, NJ—and may require up to 5% domestic or international travel.

Responsibilities

• Provide regulatory affairs support for projects related to Digital Health, Software, Cybersecurity, Electromechanical devices, and Regulatory Intelligence.
• Support pre-market and post-market regulatory activities for assigned projects.
• Collaborate with cross-functional teams to provide regulatory guidance and support.
• Prepare regulatory submissions (IDE, IDE Supplements, PMA, PMA Supplements, etc.) for the FDA and Health Canada.
• Interface with the FDA and Health Canada on assigned projects and respond to requests for additional information.
• Monitor and communicate changes to U.S. and Canadian regulatory requirements and international standards related to OrganOx products and processes.
• Formally communicate regulatory initiatives or changes in medical device laws to company personnel, customers, subcontractors, and third-party organizations.
• Perform regulatory change assessments and review applicable guidance and standards to ensure compliance.
• Prepare visualizations and conclusions for presentation to upper management.
• Work with key stakeholders on regulatory topics and adhere to OrganOx’s Code of Conduct and company policies.

Requirements

• Working knowledge of FDA processes for medical device compliance.
• Experience with Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), Cybersecurity, and Electromechanical products.
• Experience with Class II and Class III medical devices.
• Ability to write clear regulatory strategies and submissions.
• Understanding of GMP compliance requirements in Quality Control.
• Experience collaborating with Manufacturing, Quality, R&D, Clinical, and Marketing departments.
• Proficiency in MS Office (Word, Excel, PowerPoint).
• Excellent verbal and technical writing skills.
• Ability to work independently.

Qualifications

• Minimum of a Bachelor’s degree in engineering, life sciences, or a related field.
• 3–8 years of regulatory experience with Class II/III medical devices and Software products (experience level may vary based on education).
• Regulatory Affairs Certification (RAC) is optional.
• Ability to travel up to 5% of the time domestically or internationally.

Benefits

• Competitive compensation and comprehensive benefits available from day one, including health, dental, vision, and disability coverage.
• Flexible spending accounts and a 401(k)-retirement plan with company matching after 90 days.
• Paid time off, holidays, and additional leave benefits.
• Employee discounts and access to an onsite wellness facility.
• Support for work-life balance and opportunities for ongoing professional development.