Senior Regulatory Affairs Specialist

About the Company

OrganOx is a commercial-stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. Established as a spin-out of the University of Oxford in 2008 and now part of the Terumo Group, OrganOx is a pioneer in normothermic machine perfusion (NMP). Its flagship platform, the metra®, is available in the U.S., Europe, Canada, and Australia and has been used in over 7,000 liver transplants to date. The metra® keeps donor livers in a metabolically active state outside the body, enabling longer preservation times and functional assessment prior to transplant, which increases the number of organs available for transplant.

Responsibilities

• Lead and support pre-/post-market regulatory activities for assigned devices, projects, and product changes.
• Perform regulatory impact assessments for design, labeling, packaging, supplier, and manufacturing changes to determine appropriate regulatory pathways and submission requirements.
• Prepare, compile, and coordinate regulatory submissions and change notifications, including PMAs, PMA supplements, amendments, annual reports, and other change notifications or submissions.
• Support regulatory authority interactions by drafting correspondence, coordinating response strategies, tracking submission progress, and preparing responses to requests for additional information.
• Partner with project teams to define regulatory requirements, review supporting documentation, and ensure development and change activities align with applicable regulatory expectations.
• Review documentation and evidence that may support regulatory activities, including verification and validation documentation, risk management documentation, and change records.
• Contribute to departmental process improvements, regulatory intelligence activities, and internal tools or procedures that improve consistency, compliance, and efficiency.
• Provide training and support to other members of the department.
• Adhere to the letter and spirit of OrganOx's Code of Conduct and all other company policies.

This is a hybrid position in Madison, NJ, and may require up to 5% travel to OrganOx and/or supplier locations.

Requirements

• Strong experience in regulatory affairs within the medical device industry, including experience with U.S. Class III devices.
• Working knowledge of regulatory requirements outside the U.S., including Canada, Europe, United Kingdom, and other regulatory jurisdictions.
• Experience evaluating proposed product changes and determining appropriate regulatory actions.
• Experience evaluating standards (ISO, ASTM, etc.) and guidance documents for applicability and compliance requirements.
• Excellent verbal communication and technical writing skills.
• Ability to manage multiple priorities and work independently while escalating issues appropriately.
• Experience in cross-functional collaboration with Manufacturing, Quality, R&D, Operations, and Clinical.
• Experience engaging with regulatory authorities to support submissions, respond to inquiries, and facilitate successful interactions throughout the product lifecycle.

Qualifications

• Minimum of a Bachelor's degree in a technical discipline (Engineering or Life Sciences) or other related area of study.
• Minimum of 5 years of regulatory affairs experience within the medical device or similar industry.
• Demonstrated experience with successful submissions in key markets such as the U.S. and EU.
• Ability to travel 5% domestically and/or internationally.

Benefits

• Competitive compensation and comprehensive benefits available from day one, including health, dental, vision, and disability coverage.
• Flexible spending accounts.
• 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.