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 will report directly to the Director, Regulatory Affairs, Software and Innovation and collaborate with other team members within the regulatory department. This is a flexible remote or hybrid on-site position in Madison, NJ and may require up to 5% travel domestically or internationally.

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 support.
• Prepare regulatory submissions (IDE; IDE Supplements; PMA; PMA Supplements, etc.) for submission to the FDA and Health Canada.
• Interface with the FDA and Health Canada on assigned projects.
• Respond to FDA and Health Canada requests for additional information.
• Keep abreast of changes to US and Canada regulatory requirements and International Standards related to OrganOx products and processes.
• Formally communicate regulatory initiatives or changes in applicable medical device law with company personnel, customers, subcontractors, regulatory agency representatives, and third-party organizations.
• Perform regulatory change assessments as required.
• Review applicable regulatory guidance and standards for assigned projects to ensure compliance with regulations and determine regulatory impact.
• Prepare visualizations and conclusions for presentation to upper management.
• Work with key stakeholders on Regulatory topics.
• Adhere to the letter and spirit of OrganOx's Code of Conduct and all other 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 devices.
• Ability to write clear regulatory strategies and submissions.
• 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 (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 other related areas.
• Minimum 3-8 years of related regulatory experience (depending on education) with Class II/III medical devices and Software products.
• Regulatory Affairs Certification (RAC) (Optional).
• Ability to travel 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.
• 401(k)-retirement plan with company matching after 90 days.
• Paid time off, holidays, and additional leave benefits.
• Employee discounts and access to onsite wellness facility.
• Support for work-life balance and opportunities for ongoing professional development.